GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER)

Study Overview
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Brief Summary
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The objective of the study is collect data on the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface in the treatment of chronic Superficial Femoral Artery disease. Device patency at 12 months is the primary endpoint.

Official Title
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Post Marketing Study of the GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease (VIPER)

Conditions
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Peripheral Vascular Diseases

Intervention / Treatment
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* Device: Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:> lifestyle limiting claudication, rest pain or minor tissue loss> ABI (ankle-brachial index) < 0.9 or TBI (toe-brachial index) < 0.5 if ABI is >0.9 Stenosis (>50%) or occlusion of native SFA (superficial femoral artery) >5cm Orifice and 1 cm of SFA are patent Popliteal artery is patent at the intercondylar fossa of the femur to the trifurcation At least 1 patent run off vessel Guidewire and deliver system successfully traversed the lesion Exclusion Criteria:> Untreated flow-limiting aortoiliac occlusive disease Any previous stenting or surgery in the target vessel Femoral or popliteal aneurysm of target vessel No patent tibial arteries Prior ipsilateral femoral artery bypass Major distal amputation (above the transmetatarsal) in either limb Patients with known sensitivity to Heparin

Ages Eligible for Study
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Minimum Age: 18 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: GORE VIABHAN Endoprothesis<br>Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface | Device: Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface<br>* Endovascular treatment of the study lesion with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Patency at 12 Months | Primary patency is defined as no evidence of restenosis (repeat narrowing) or occlusion (total blockage) within the originally treated lesion based on color-coded duplex sonography (color Doppler ultrasound (CDUS). The Peak Systolic Velocity Ratio must be less than 2.5 (PSVR: the result of taking the highest rate of blood flow within the stented region and dividing it by the highest rate of blood flow just above the stented area). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects Who Experience Major Device-related Adverse Events Within the First 30 Days | If the functioning or characteristics of the device caused or contributed significantly to the adverse event,and if they occurred within 30 days of the procedure, they would be considered major adverse events (MAEs). Major AEs require significant therapy, including an unplanned increase in the level of care, permanent sequelae, hospitalization, or death. | 30 days | 
| Primary Assisted Patency | Primary assisted patency is defined as patency in the target lesion maintained by repeat intervention (one or more follow-up procedures) in an attempt to salvage the stent prior to complete occlusion (blockage) of the treated arterial segment, and also includes patients with primary patency. | 12 months | 
| Secondary Patency | Secondary patency is defined as patency in the target lesion maintained by repeat intervention (one more more follow-up procedures) after complete occlusion (blockage) of the treated arterial segment, and also includes patients that have primary and primary assisted patency. | 12 months | 
| Device-related Major Adverse Events at 12 Months | If the functioning or characteristics of the device caused or contributed significantly to the adverse event (AE), the AE would be related to the device. Major AEs require significant therapy, including an unplanned increase in the level of care, permanent sequelae, hospitalization, or death. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Arterial Disease, Peripheral Vascular Disease