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

W.L.Gore & Associates119 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

119

Conditions

Peripheral Vascular Diseases

Interventions

Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive SurfaceDEVICE

Endovascular treatment of the study lesion with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Tri-City Medical Center

Oceanside, California, United States

Mercy Hospital and Medical Center

Chicago, Illinois, United States

Columbia Surgical Associates

Columbia, Missouri, United States

Baylor University Medical Center

Dallas, Texas, United States

Outcomes

Primary Outcomes

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).

Time frame: 12 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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