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

Not Applicable

Completed

• Conditions: Peripheral Vascular Diseases

• Registration Number: NCT00541307
• Lead Sponsor: W.L.Gore & Associates

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-09
• Study First Submitted QC: 2007-10-09
• Study First Posted: 2007-10-10
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2012-06-22
• Status Verified: 2012-11
• Results First Submitted QC: 2012-11-26
• Last Update Submitted: 2012-11-26
• Results First Posted: 2012-12-27
• Last Update Posted: 2012-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

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• 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

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• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary Patency at 12 Months	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).

Secondary Outcome Measures

Name	Time	Method
Proportion of Subjects Who Experience Major Device-related Adverse Events Within the First 30 Days	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.
Primary Assisted Patency	12 months	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.
Secondary Patency	12 months	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.
Device-related Major Adverse Events at 12 Months	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.

Trial Locations

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

St. Luke's Medical Center; 🇺🇸 Milwaukee, Wisconsin, United States