ClosureFAST - Radiofrequency Great Saphenous Vein Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Venous Reflux

Intervention / Treatment
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* Device: RF ablation (ClosureFAST)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Seg. RF Ablation with CLF catheter<br>Single Arm with CLF Catheter | Device: RF ablation (ClosureFAST)<br>* Segmental RF Ablation with the CLF catheter<br>* Other names: CLosureFAST;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Limbs Without Vein Occlusion | 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. | 6 Months | 
| Percentage of Limbs Without Vein Occlusion | 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. | 12 months | 
| Percentage of Limbs Without Vein Occlusion | 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. | 2 years | 
| Percentage of Limbs Without Vein Occlusion | 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 years | 
| Percentage of Limbs Without Vein Occlusion | 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. | 4 years | 
| Percentage of Limbs Without Vein Occlusion | 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 years | 
| Percentage of Limbs Without Reflux in the Treated Vein Segment | 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. | 6 months | 
| Percentage of Limbs Without Reflux in the Treated Vein Segment | 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 months | 
| Percentage of Limbs Without Reflux in the Treated Vein Segment | 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. | 2 years | 
| Percentage of Limbs Without Reflux in the Treated Vein Segment | 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. | 3 years | 
| Percentage of Limbs Without Reflux in the Treated Vein Segment | 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. | 4 years | 
| Percentage of Limbs Without Reflux in the Treated Vein Segment | 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. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CEAP (Clinical, Etiologic, Anatomic, and Pathophysiologic) Classification | 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. | Baseline | 
| CEAP Classification | 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. | 1 Week | 
| CEAP Classification | 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 months | 
| CEAP Classification | 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. | 12 months | 
| CEAP Classification | 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 years | 
| Change in Venous Clinical Severity Score (VCSS) From Baseline to 5Y Follow-up | 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. | Baseline thru 5 years | 
| Visual Analog Pain Scale (VAS) | 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 | 5 years | 
| Presence of Complications From Greater Saphenous Vein (GSV) Intervention | Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention. | 1 Week | 
| Presence of Complications From GSV Intervention | Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention. | 3 Months | 
| Presence of Complications From GSV Intervention | Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention. | 12 months | 
| Presence of Complications From GSV Intervention | Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GSV, RadioFrequency