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Completed

NCT Number: NCT03455699

VeClose Five Year Follow-Up Extension Study

The VeClose Five Year Follow-up Extension Study will seek to gain additional follow-up data from the patients enrolled in the VeClose study (NCT01807585).

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Key information

Conditions

Great Saphenous Vein (GSV) With Venous Reflux Disease

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Morrison Vein Institute, Scottsdale, Arizona, United States

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About this study

The VeClose Five Year Follow-up Extension Study will continue to assess the safety and efficacy of the VenaSeal Closure System for the long term effect on closure of the great saphenous vein by conducting a follow-up visit at five years post index procedure/enrollment in the VeClose study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Enrolled in the VeClose study.
  • Able and willing to complete the required 5 year study visit including Duplex ultrasound exam.
  • Able and willing to provide written informed consent prior to study specific data collection.

Exclusion criteria

  • Withdrew consent from the VeClose study.

Treatment and study plan

VenaSeal SCS

Device

Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.

Other names: VenaSeal Sapheon Closure System, VSCS

ClosureFast Radiofrequency Ablation (RFA)

Device

Radiofrequency thermal ablation of the GSV using the Covidien ClosureFast system.

Other names: ClosureFast

Roll-In (VenaSeal SCS)

Device

Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.

Other names: VenaSeal Sapheon Closure System, VSCS, Roll-in

Primary outcomes

  1. Complete Closure of the Target Vein at 5 years after index treatment in the VeClose study (NCT01807585).

    Time frame: 5 years

    Complete closure is defined as Doppler ultrasound examination showing closure along entire treated target vein segment with no discrete segments of patency exceeding 5cm.

Secondary outcomes

  1. Venous Clinical Severity Score (VCSS)

    Time frame: 5 years

    Change in Venous Clinical Severity Score (VCSS) at 5 years as compared to baseline data from the VeClose study (NCT01807585). The VCSS is an Investigator assessment of the severity of venous reflux disease, assessing signs and symptoms such as pain, varicose veins, venous edema, skin pigmentation, induration and inflammation. The VCSS score is the sum of responses to 10 questions. Each question has a total possible of 3 points, which are then added for each question. The overall VCSS scores can therefore range from 0 (no venous disease) to 30 (severe venous disease). High scores indicate worse outcomes and "0" is the best possible outcome.

  2. Aberdeen Varicose Vein Questionnaire (AVVQ)

    Time frame: 5 years

    Change in Aberdeen Varicose Vein Questionnaire (AVVQ) at 5 years as compared to baseline data from the VeClose study (NCT01807585). AVVQ is a disease-specific 13-item questionnaire used to assess the impact of varicose veins on the quality of life, such as pain caused by varicose veins, and need to take painkilling tablets for varicose veins as well as assessing the presence of signs/symptoms such as ankle swelling, purple discoloration and rash/eczema. The total score of AVVQ is the sum of all questions for each leg. Scores range from 0 (no disease) to 100 (maximal disease). High scores indicate worse outcomes and "0" is the best possible outcome.

  3. Quality of Life survey (EQ-5D)

    Time frame: 5 years

    Change in Quality of Life survey (EQ-5D) at 5 years as compared to baseline data from the VeClose study (NCT01807585). EQ-5D is a short generic quality of life survey that is commonly used outside of the United States for health technology assessments. The "health state today" question provides an overall assessment along a 20-cm visual analog scale (VAS) with a range from 0 ("worst imaginable health state") to 100 ("best imaginable health state").

  4. CEAP classification ("clinical, etiology, assessment and pathophysiology")

    Time frame: 5 years

    Standardized measure of the degree of venous insufficiency and secondary manifestations of venous disease as measured by the treating physician.

  5. Satisfaction with Treatment

    Time frame: 5 years

    Satisfaction with Treatment assessment consists of a brief 2-question patient survey rating satisfaction with treatment provided and whether the subject would undergo the assigned treatment again. The number (percent) of subjects on each level of satisfaction are summarized (Very satisfied, Somewhat satisfied, Somewhat dissatisfied, Very dissatisfied). The number (percent) of subjects for the second satisfaction question, "would undergo treatment again" were also summarized by response (Definitely have again, Might have again, Not have again).

  6. Adverse events (AE) related to the target GSV

    Time frame: 5 years

    AEs related to the GSV will be tabulated and reporting using the MedDRA dictionary, version 16.1.

  7. Adjunctive procedures performed on the study limb

    Time frame: 5 years

    Details of adjunctive procedures performed on the study limb will be captured on Case Report Forms (CRFs)

Sponsors and collaborators

Lead sponsor

Medtronic Endovascular

Industry

Registry information

Official study title

Follow-up of Patients Treated in VeClose Study (Five Years)

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 6, 2018
Registry last updated
Apr 12, 2019

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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