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Completed

NCT Number: NCT00842296

ClosureFAST - Radiofrequency Great Saphenous Vein Treatment

The purpose of this study is to confirm that the ClosureFAST system can be used as an alternative to the current ClosurePlus catheter for treating the GSV and to accumulate pivotal data for optimization of the operating parameters.

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Key information

Conditions

Venous Reflux

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The purpose of this study is to confirm that the ClosureFAST system can be used as an alternative to the current ClosurePlus catheter for treating the GSV and to accumulate pivotal data for optimization of the operating parameters. The results from this study will be used to further evaluate the risks and benefits of the ClosureFAST device and to obtain clinical evidence that the treatment provides effective and durable clinical outcomes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 18 and 80 years of age at the time of enrollment
  • Symptomatic lower limb venous disease involving the GSV

Exclusion criteria

  • Thrombosis in the vein segment to be treated
  • Known or suspected pregnancy or actively breast feeding at time of treatment

Treatment and study plan

RF ablation (ClosureFAST)

Device

Segmental RF Ablation with the CLF catheter

Other names: CLF, CLosureFAST

Primary outcomes

  1. Percentage of Limbs Without Vein Occlusion

    Time frame: 6 Months

    Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up Duplex Ultrasound (DU) scan. Flow which originates in the Saphenofemoral Junction (SFJ) and which measures < 3 cm in length, does not constitute a failure.

  2. Percentage of Limbs Without Vein Occlusion

    Time frame: 12 months

    Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure.

  3. Percentage of Limbs Without Vein Occlusion

    Time frame: 2 years

    Vein occlusion is defined as the absence of flow in the treated vein as documented on the post-procedure and each successive follow-up DU scan.

  4. Percentage of Limbs Without Vein Occlusion

    Time frame: 3 years

    Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure.

  5. Percentage of Limbs Without Vein Occlusion

    Time frame: 4 years

    Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure.

  6. Percentage of Limbs Without Vein Occlusion

    Time frame: 5 years

    Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure.

  7. Percentage of Limbs Without Reflux in the Treated Vein Segment

    Time frame: 6 months

    No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.

  8. Percentage of Limbs Without Reflux in the Treated Vein Segment

    Time frame: 12 months

    No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.

  9. Percentage of Limbs Without Reflux in the Treated Vein Segment

    Time frame: 2 years

    No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.

  10. Percentage of Limbs Without Reflux in the Treated Vein Segment

    Time frame: 3 years

    No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.

  11. Percentage of Limbs Without Reflux in the Treated Vein Segment

    Time frame: 4 years

    No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.

  12. Percentage of Limbs Without Reflux in the Treated Vein Segment

    Time frame: 5 years

    No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.

Secondary outcomes

  1. CEAP (Clinical, Etiologic, Anatomic, and Pathophysiologic) Classification

    Time frame: Baseline

    Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at baseline. The CEAP clinical Categories are as follows where C1 is of the least clinical concern and C6 is the worst stage; C1- Reticular and spider veins C2- Varicose veins C3- Varicose veins and leg swelling C4- Varicose veins and evidence of venous stasis skin changes C5- Varicose veins and a healed venous stasis ulceration C6- Varicose veins and an open venous ulceration

    Reference: Kistner RL, Eklof B, Masuda EM. Diagnosis of chronic venous disease of the lower extremities: The "CEAP" classification. Mayo Clinic Proc 1996;71:338-45.

  2. CEAP Classification

    Time frame: 1 Week

    Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at follow-up where C1 is the best and C6 is the worst in terms of clinical status.

  3. CEAP Classification

    Time frame: 3 months

    Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at follow-up where C1 is the best and C6 is the worst in terms of clinical status.

  4. CEAP Classification

    Time frame: 12 months

    Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at follow-up where C1 is the best and C6 is the worst in terms of clinical status.

  5. CEAP Classification

    Time frame: 5 years

    Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at follow-up where C1 is the best and C6 is the worst in terms of clinical status.

  6. Change in Venous Clinical Severity Score (VCSS) From Baseline to 5Y Follow-up

    Time frame: Baseline thru 5 years

    Status of clinical signs and symptoms of lower limb venous disease evaluated using standardized scales and subject responses to post-procedure standardized questions - VCSS Status from Baseline to 5 years. VCSS assesses 10 factors of venous disease whereby each factor is graded on a severity scale of 0-3 (least to worst). The higher the VCSS score the most severe the clinical signs and symptoms of venous disease are in a patient. VCSS improvement over time is presented by a decrease in VCSS total score (maximum score = 30; minimum score = 0).

    Reference: Rutherford RB, Padberg FT Jr, Comerota AJ, Kistner RL, Meissner MH, Moneta GL. Venous severity scoring: An adjunct to venous outcome assessment. J Vasc Surg 2000;31:1307-12.

  7. Visual Analog Pain Scale (VAS)

    Time frame: 5 years

    Status of clinical signs and symptoms of lower limb venous disease evaluated using standardized scales and subject responses to post-procedure standardized questions - VAS for pain scored from 0-10 with 10 being worst possible pain

  8. Presence of Complications From Greater Saphenous Vein (GSV) Intervention

    Time frame: 1 Week

    Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.

  9. Presence of Complications From GSV Intervention

    Time frame: 3 Months

    Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.

  10. Presence of Complications From GSV Intervention

    Time frame: 12 months

    Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.

  11. Presence of Complications From GSV Intervention

    Time frame: 5 years

    Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.

Sponsors and collaborators

Lead sponsor

Medtronic Endovascular

Industry

Registry information

Official study title

ClosureFAST - Endovascular Radiofrequency Great Saphenous Vein Treatment Using a Catheter With an Integrated Heating Element

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Feb 12, 2009
Registry last updated
Mar 12, 2018

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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