EU Post Market Clinical Follow-Up Study of the Venclose System for Saphenous Vein Incompetence

Study Overview
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Brief Summary
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This is a prospective, non-randomized study in which patients who meet eligibility criteria and consent to participate will undergo a minimally invasive procedure using radiofrequency (RF) energy for ablation of the great saphenous vein (GSV).

Detailed Description
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Subjects who meet eligibility criteria will undergo a procedure using the Venclose Radiofrequency (RF) System to treat the great saphenous vein. The technique involves percutaneous access and insertion of the endovenous sectional radiofrequency (EVSRF™) catheter into the target vein under ultrasound guidance and relies on the use of local anesthesia and thermal energy, from a radiofrequency generator, applied to the target vein. After each treatment, the EVSRF™ catheter is withdrawn a single length of the heating coil and another treatment is performed, until the entire vessel has been treated. After the treatment procedure, subjects will be evaluated four (4) times to assess vein recanalization and reflux, and to determine the incidence of adverse events.

Official Title
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EU Post Market Clinical Follow-Up Study of the Venclose System for Saphenous Vein Incompetence

Conditions
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Chronic Venous Insufficiency

Intervention / Treatment
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* Device: Venclose RF System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is male or female and 18 to 80 years old (inclusive) at time of enrollment (signing of consent). Subject has significant venous reflux by Duplex Ultrasound (DUS), defined as reverse flow with reflux duration greater than 0.5 seconds after the Valsalva maneuver or distal augmentation while the patient is standing or in reverse Trendelenburg position. Subject is eligible for endovascular treatment, as determined by the treating investigator. Subject's general physical condition allows for a significant amount of ambulation after the procedure, as determined by the treating investigator. Subject is willing and able to complete study requirements, including all follow-up visits and assessments. Subject voluntarily provides written informed consent to participate in this study. Exclusion Criteria: There is evidence of old or fresh thrombus in the subject's diseased vein segment to be treated, as determined by Duplex Ultrasound (DUS) within 2 weeks prior to the index procedure. In the judgment of the treating investigator heat energy delivery to the subject would be contraindicated. Subject is concurrently participating in another interventional clinical trial. Subject is pregnant or plans to be pregnant or lactating at the time of the treatment procedure. Subject has known or suspected allergies or contraindications to any general or local anesthetic agents and/or any antibiotic medication that cannot be adequately pre-treated.

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 |
| --- | --- |
| Other: Venclose RF System<br>Treatment of great saphenous vein (GSV) using Venclose RF System | Device: Venclose RF System<br>* Treatment of great saphenous vein (GSV) using Venclose RF System<br>* Other names: RF ablation, EVSRF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vein Occlusion Rate | Percentage of limbs with occlusion of the treated vein | 3 days | 
| Vein Occlusion Rate | Percentage of limbs with occlusion of the treated vein | 3 months | 
| Vein Occlusion Rate | Percentage of limbs with occlusion of the treated vein | 6 months | 
| Vein Occlusion Rate | Percentage of limbs with occlusion of the treated vein | 12 months | 
| Reflux-free Rate | Percentage of limbs without reflux in the treated vein | 3 days | 
| Reflux-free Rate | Percentage of limbs without reflux in the treated vein | 3 months | 
| Reflux-free Rate | Percentage of limbs without reflux in the treated vein | 6 months | 
| Reflux-free Rate | Percentage of limbs without reflux in the treated vein | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification | Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer) | Baseline | 
| Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification | Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer) | 3 days | 
| Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification | Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer | 3 months | 
| Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification | Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer) | 6 months | 
| Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification | Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer) | 12 months | 
| Venous Clinical Severity Score (VCSS) | Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe)) | Baseline | 
| Venous Clinical Severity Score (VCSS) | Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe)) | 3 days | 
| Venous Clinical Severity Score (VCSS) | Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe)) | 3 months | 
| Venous Clinical Severity Score (VCSS) | Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe)) | 6 months | 
| Venous Clinical Severity Score (VCSS) | Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe)) | 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 | up to 3 days | 
| 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 | 6 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GSV, superficial vein reflux, venous reflux, venous insufficiency, varicose veins