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Terminated

NCT Number: NCT03820947

VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial

Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early and Advanced Stage Superficial Venous Disease

Why the study stopped: Follow-up of the VenaSeal vs. Endothermal Ablation and Venous Leg Ulcer studies was concluded early due to increased evidence of safety and effectiveness of VenaSeal in published literature and to reduce burden to investigators and sites.
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Key information

Conditions

Venous Reflux Cardiovascular Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunshine Coast University Hospital, Birtinya, Australia

Loading trial locations.

About this study

The study is designed with two randomized studies and one single arm study.

Two randomized studies are for CEAP 2-5 subjects:

  • VenaSeal vs. Surgical Stripping Study (outside of the United States only)
  • VenaSeal vs. ETA Study

The single arm study is for CEAP 6 subjects with active venous leg ulcers (VLU):

  • VLU Study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient is ≥18 years of age
  • Patient has venous reflux in superficial truncal vein(s) (e.g., GSV, SSV, accessory saphenous veins) with CEAP 2 (symptomatic) or CEAP 3, 4a, 4b, 5, 6, appropriate for treatment, as confirmed by Duplex Ultrasound (DUS)
  • Eligibility for treatment:
  • VenaSeal vs ETA Study: Patient is eligible for treatment with the VenaSeal™ system and ETA
  • VenaSeal vs Surgical Stripping Study: Patient is eligible for treatment with the VenaSeal™ system and surgical stripping
  • VLU Study: patients should be eligible for treatment with the VenaSeal™ system
  • Treatable refluxing segment of target vein(s) 10 cm in length or longer
  • Patient has a target vein diameter of ≥3 mm throughout the intended treated segment of the target vein as measured by DUS while patient is standing
  • Patient is willing and capable of complying with specified follow-up evaluations at the specified times
  • Patient has an ability to understand the requirements of the study and to provide informed consent

Exclusion criteria

  • Patient has a known history of allergic sensitivities (including but not limited to cyanoacrylate adhesives), or any other condition, which in the opinion of the investigator may make the patient more susceptible to cyanoacrylate adhesive hypersensitivity
  • Patient has known deep vein obstruction in the target limb, as identified by the site's standard of care
  • Patient has abnormal pulse exam or Ankle-Brachial Index (ABI) <0.8
  • Patient has acute superficial thrombophlebitis
  • Patient requires any non-target vein treatments in the contralateral or ipsilateral limb, or any other surgical procedure up tp 30 days pre-procedure and through 3 months post-procedure
  • Patient has any co-morbid conditions, which in the investigator's opinion may interfere with the patient's compliance with study visits and procedures, or may confound interpretation of study data (e.g., congestive heart failure Class III and IV, non-ambulatory patients, severe hepatic dysfunction, life expectancy < 1 year)
  • Instructions for Use (IFU) contraindications:
  • VenaSeal vs. ETA Study: Patient has VenaSeal™ system and/or ETA product's IFU contraindication(s)
  • VenaSeal vs Surgical Stripping Study: Patient has surgical stripping and/or VenaSeal™ system IFU contraindication(s)
  • VLU Study: Patient has VenaSeal™ system IFU contraindication(s)
  • Patient is non-ambulatory
  • Patient is a female of childbearing potential who may be pregnant or breastfeeding at the time of the index procedure
  • Patient belongs to a vulnerable population per investigator's judgment or patient has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures
  • Patient is currently participating in an investigational drug or device study when the data collected could be conflicting or biased due to participation in another study
  • Patient has documented COVID-19 infection currently or within the past 3 months. Patient is not completely recovered from past COVID-19 infection, per physician's discretion.
  • VLU Study: Patient has target ulceration identified to be of non-venous etiology, as confirmed by the independent core laboratory
  • VLU Study: Patient has target circumferential ulceration that cannot be captured in a single photograph (any ulcer curvature around the leg that goes out of sight)

Treatment and study plan

VenaSeal™ System

Device

The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.

Endothermal Ablation (ETA)

Device

ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein.

Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.

Other names: Endovenous laser ablation (EVLA), Radiofrequency ablation (RFA)

Surgical Stripping

Procedure

Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.

Primary outcomes

  1. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days.

    Time frame: 30 days

    Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe).

    Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction.

  2. Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days.

    Time frame: 30 days

    Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe).

    Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction.

  3. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days.

    Time frame: 30 days

    Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs).

    Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction.

  4. Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days.

    Time frame: 30 days

    Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs).

    Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction.

  5. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Each Target Vein at the Time of Index Procedure.

    Time frame: Post Index procedure, on the day of the procedure immediately following treatment

    Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.

  6. Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Each Target Vein at the Time of Index Procedure.

    Time frame: Post Index procedure, on the day of the procedure immediately following treatment

    Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.

  7. Single Arm Venous Leg Ulcer (VLU) Study: Primary Endpoint: Time to Ulcer Healing, Calculated Through Healing Confirmation and Verified by an Independent Core Laboratory Through 12 Months.

    Time frame: 12 months

    Time to ulcer healing reported by using the cumulative incidence probability estimate of the event happening at 12 months, expressed as a percentage. The data values below represent the cumulative incidence probability as a percentage of participants with ulcer healing through 12 months.

Secondary outcomes

  1. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months.

    Time frame: 6 months

    Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system and ETA procedures.

    Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months.

  2. Randomized Study VenaSeal™ System Versus Surgical Stripping: Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months.

    Time frame: 6 months

    Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual primary target vein after surgical stripping procedures.

    Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months.

  3. Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months.

    Time frame: 6 months

    Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system.

    Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months.

  4. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Key Secondary Endpoint: Time to Return to Work as Reported by the Patient.

    Time frame: 30 days

    Time to return to work reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to work through 30 days.

  5. Randomized Study VenaSeal™ System Versus Surgical Stripping: Key Secondary Endpoint: Time to Return to Work as Reported by the Patient.

    Time frame: 30 days

    Time to return to work reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to work through 30 days.

  6. Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Key Secondary Endpoint: Time to Return to Work as Reported by the Patient.

    Time frame: 30 days

    Time to return to work reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to work through 30 days.

  7. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12, 24, 36, 48 and 60 Months.

    Time frame: 30 days and 12, 24, 36, 48 and 60 months

    For subjects treated with the VenaSeal™ system or ETA it is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.

    Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days and 12, 24, 36, 48 and 60 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure at 30 days and 12, 24, 36, 48 and 60 months.

  8. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12 Months.

    Time frame: 30 days, 12 months

    Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual primary target vein after surgical stripping procedures.

    Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 30 days and 12 months.

  9. Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12, 24, 36, 48 and 60 Months.

    Time frame: 30 days, 12 months, 24 months, 36 months, 48 months and 60 months

    For subjects treated with the VenaSeal™ system it is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.

    Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, 12 months, 24 months, 36 months, 48 months and 60 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure tat 30 days, 12 months, 24 months, 36 months, 48 months and 60 months

  10. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months.

    Time frame: 30 days, and 6, 12, 24, 36, 48 and 60 months

    For subjects treated with the VenaSeal™ system or ETA this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.

    Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, and 6, 12, 24, 36, 48 and 60 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins with anatomic closure through 30 days, and 6, 12, 24, 36, 48 and 60 months.

  11. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12 Months.

    Time frame: 30 days, 6, 12 months

    Anatomic closure of target superficial truncal vein defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual primary target vein after surgical stripping procedures.

    Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, 6 months, and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins with anatomic closure through 30 days, 6 months, and 12 months.

  12. Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months.

    Time frame: 30 days, and 6, 12, 24, 36, 48 and 60 months.

    For subjects treated with the VenaSeal™ system this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.

    Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, and 6, 12, 24, 36, 48 and 60 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins with anatomic closure at 30 days, and 6, 12, 24, 36, 48 and 60 months.

  13. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure.

    Time frame: Post Index procedure, on the day of the procedure immediately following treatment

    For subjects treated with the VenaSeal™ system or ETA this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.

  14. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure.

    Time frame: Post Index procedure, on the day of the procedure immediately following treatment

    Defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual vein after surgical stripping procedures.

  15. Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure.

    Time frame: Post Index procedure, on the day of the procedure immediately following treatment

    For subjects treated with the VenaSeal™ system this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.

  16. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Reintervention of Any Target Vein (Including Primary Target Vein) Through 12 Months, Assessed at Each Follow-up Visit.

    Time frame: 12 months

  17. Randomized Study VenaSeal™ System Versus Endothermal Ablation: Secondary Endpoint: Reintervention of Any Target Vein (Including Primary Target Vein) Through 60 Months, Assessed at Each Follow-up Visit.

    Time frame: 60 months

  18. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Time to Reintervention of Any Target Vein (Including Primary Target Vein) Through 12 Months.

    Time frame: 12 months

    As measured by the time between the index procedure and the first reintervention procedure.

    Time to reintervention was reported by using the event free Kaplan-Meier survival probability estimate at 12 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins without a reintervention through 12 months.

  19. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months.

    Time frame: 12 months

    Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT) or endovenous heat induced thrombosis (EHIT), Symptomatic deep vein thrombosis (DVT) events.

  20. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months.

    Time frame: 12 months

    Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT), Symptomatic deep vein thrombosis (DVT) events.

  21. Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months.

    Time frame: 12 months

    Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT), Symptomatic deep vein thrombosis (DVT) events.

  22. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Additional Events Evaluated Through 12 Months.

    Time frame: 12 months

    Symptomatic pulmonary embolism (PE), Serious adverse events (SAEs).

  23. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure.

    Time frame: 12 months

  24. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure.

    Time frame: 12 months

  25. Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure.

    Time frame: 12 months

  26. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Healthcare Utilization Related to the Target Limb VRD.

    Time frame: 12 months

    Determined by the number of healthcare visits conducted, and other health-related resources utilized (e.g., home healthcare services) between study visits through 12 months.

  27. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months.

    Time frame: 12 months

  28. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients.

    Time frame: 30 days

    Time to return to normal activities reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to normal activities through 30 days.

  29. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients.

    Time frame: 30 days

    Time to return to normal activities reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to normal activities through 30 days.

  30. Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients.

    Time frame: 30 days

    Time to return to normal activities reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to normal activities through 30 days.

  31. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days.

    Time frame: Intra-procedure, post-procedure (on the day of the procedure immediately following treatment), 7 days and 30 days

    Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.

  32. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days.

    Time frame: Intra-procedure, post-procedure (on the day of the procedure immediately following treatment), 7 days and 30 days

    Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.

  33. Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days.

    Time frame: Intra-procedure, post-procedure (on the day of the procedure immediately following treatment), 7 days and 30 days

    Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.

  34. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.

    Time frame: 7 and 30 days, and at 6, 12, 24, 36 and 60 months

    Measured by the revised Venous Clinical Severity Score (rVCSS) and subject self-reporting.

    rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease.

    The outcome measure data reports changes compared to baseline at the different time frames.

  35. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12 Months Compared to Baseline.

    Time frame: 7 and 30 days, and at 6 and 12 months

    Measured by the revised Venous Clinical Severity Score (rVCSS) and subject self-reporting.

    rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease.

    The outcome measure data reports changes compared to baseline at the different time frames.

  36. Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.

    Time frame: 7 and 30 days, and at 6, 12, 24, 36 and 60 months

    Measured by the revised Venous Clinical Severity Score (rVCSS) and subject self-reporting.

    rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease.

    The outcome measure data reports changes compared to baseline at the different time frames.

  37. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in Aberdeen Varicose Vein Questionnaire (AVVQ) Score at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.

    Time frame: 30 days, and at 6, 12, 24, 36, 48 and 60 months

    The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life.

    The outcome measure data reports changes compared to baseline at the different time frames.

  38. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6 and 12 Months Compared to Baseline.

    Time frame: 30 days, and 6 and 12 months

    The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life.

    The outcome measure data reports changes compared to baseline at the different time frames.

  39. Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.

    Time frame: 30 days, and at 6, 12, 24, 36 and 60 months

    The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life.

    The outcome measure data reports changes compared to baseline at the different time frames.

  40. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6, 12, 24, 36, 48 and 60 Months Compared to Baseline.

    Time frame: 30 days, and 6, 12, 24, 36, 48 and 60 months

    EQ-5D Index scale from <0 to 1.0 (<0 worse than dead, 0 is dead and 1.0 is full health).

    The outcome measure data reports changes compared to baseline at the different time frames.

  41. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6 and 12 Months Compared to Baseline.

    Time frame: 30 days, and 6 and 12 months

    EQ-5D Index scale from <0 to 1.0 (<0 worse than dead, 0 is dead and 1.0 is full health).

    The outcome measure data reports changes compared to baseline at the different time frames.

  42. Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6, 12, 24, 36, 48 and 60 Months Compared to Baseline.

    Time frame: 30 days, and 6, 12, 24, 36, 48 and 60 months

    EQ-5D Index scale from <0 to 1.0 (<0 worse than dead, 0 is dead and 1.0 is full health).

    The outcome measure data reports changes compared to baseline at the different time frames.

  43. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline.

    Time frame: 30 days, and 6 and 12 months

    The total score ranges from 0 to 100, with higher scores indicating better general health perception.

    The outcome measure data reports changes compared to baseline at the different time frames.

  44. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline.

    Time frame: 30 days, and 6 and 12 months

    The total score ranges from 0 to 100, with higher scores indicating better general health perception.

    The outcome measure data reports changes compared to baseline at the different time frames.

  45. Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline.

    Time frame: 30 days, and 6 and 12 months

    The total score ranges from 0 to 100, with higher scores indicating better general health perception.

    The outcome measure data reports changes compared to baseline at the different time frames.

  46. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.

    Time frame: 30 days, and 6, 12, 24, 36, 48, and 60 months

    The Generic VenousDQOL score was calculated as the average of the Quality of Life scores measured on an interval from +3 (Excellent) to -3 (Extremely Bad).

    The outcome measure data reports the responses at the different time points compared to baseline.

  47. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline.

    Time frame: 30 days, and 6, 12 months

    The Generic VenousDQOL score was calculated as the average of the Quality of Life scores measured on an interval from +3 (Excellent) to -3 (Extremely Bad).

    The outcome measure data reports the responses at the different time points compared to baseline.

  48. Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.

    Time frame: 30 days, and 6, 12, 24, 36, 48, and 60 months

    The Generic VenousDQOL score was calculated as the average of the Quality of Life scores measured on an interval from +3 (Excellent) to -3 (Extremely Bad).

    The outcome measure data reports the responses at the different time points compared to baseline.

  49. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure.

    Time frame: Post-index procedure, on the day of the procedure immediately following treatment

    Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).

  50. Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure.

    Time frame: Post-index procedure, on the day of the procedure immediately following treatment

    Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).

  51. Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure.

    Time frame: Post-index procedure, on the day of the procedure immediately following treatment

    Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).

  52. Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days.

    Time frame: 30 days

    Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe).

    Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction.

  53. Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Patient Satisfaction as Measured by a Validated Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days.

    Time frame: 30 days

    Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs).

    Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction.

  54. Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Target Vein at the Time of Index Procedure as Measured by the Percentage of Target Veins Successfully Treated.

    Time frame: Post-index procedure, on the day of the procedure immediately following treatment

    Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.

  55. Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Reintervention of Any Target Vein (Including Primary Target Vein) Through 60 Months, Assessed at Each Follow-up Visit.

    Time frame: 60 months

  56. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Healthcare Utilization Related to the Target Limb VRD.

    Time frame: 60 months

    Determined by the number of healthcare visits conducted, and other health-related resources utilized (e.g., home healthcare services) between study visits through 60 months

  57. Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Healthcare Utilization Related to the Target Limb VRD.

    Time frame: 60 months

    Determined by the number of healthcare visits conducted, and other health-related resources utilized (e.g., home healthcare services) between study visits through 60 months.

  58. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 60 Months.

    Time frame: 60 months

  59. Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 60 Months.

    Time frame: 60 months

  60. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Time to Reintervention of Any Target Vein (Including Primary Target Vein) Through 60 Months.

    Time frame: 60 months

    As measured by the time between the index procedure and the first reintervention procedure.

    Time to reintervention was reported by using the event free Kaplan-Meier survival probability estimate at 60 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins without a reintervention through 60 months.

  61. Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Secondary Endpoint: Time to Reintervention of Any Target Vein (Including Primary Target Vein) Through 60 Months.

    Time frame: 60 months

    As measured by the time between the index procedure and the first reintervention procedure.

    Time to reintervention was reported by using the event free Kaplan-Meier survival probability estimate at 60 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins without a reintervention through 60 months.

  62. Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Time to Ulcer Recurrence on the Target Limb Following Ulcer Healing Through 60 Months.

    Time frame: 60 months

    Time to ulcer recurrence reported by using the cumulative incidence probability estimate of the event happening at 60 months, expressed as a percentage. Ulcer recurrence could only occur after the initial ulcer had completely healed.

  63. Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Ulcer Free Time, Calculated as Days Between Initial Ulcer Healing and First Ulcer Recurrence, as Applicable, Through 60 Months.

    Time frame: 60 months

    As measured by the time between initial ulcer healing and the first ulcer recurrence.

  64. Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Ulcer Healing Rate, as Measured by the Percentage of the Ulcer Area Healed, Through 24 Months.

    Time frame: 24 months

    Ulcer healing rate, as measured by the percentage of the ulcer area healed, according to an independent core laboratory through 24 months or until ulcer healing has been confirmed. This was assessed by overall number of wound care utilizations, and also by different wound care treatments subtypes.

  65. Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Healthcare Utilization and Routine Wound Care Treatments Between Study Visits Through 60 Months.

    Time frame: 60 months

    Determined by the number of ulcer wound care treatments utilized between study visits through 60 months.

  66. Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Additional Events Evaluated Through 60 Months.

    Time frame: 60 Months

    Symptomatic pulmonary embolism (PE), Serious adverse events (SAEs).

  67. Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Additional Events Evaluated Through 60 Months.

    Time frame: 60 Months

    Symptomatic pulmonary embolism (PE), Serious adverse events (SAEs).

Sponsors and collaborators

Lead sponsor

Medtronic Endovascular

Industry

Registry information

Official study title

Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early & Advanced Stage Superficial Venous Disease

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Jan 29, 2019
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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