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

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

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 Overview

• Status: Completed
• Conditions: Peripheral Vascular Diseases
• Intervention / Treatment: Device: Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Oceanside, California, United States, 92056
      • Tri-City Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60616
      • Mercy Hospital and Medical Center
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Columbia Surgical Associates
  • Texas
    • Dallas, Texas, United States, 75226
      • Baylor University Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53233
      • St. Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GORE VIABHAN Endoprothesis; Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface	Device: Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface; Endovascular treatment of the study lesion with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: Richard Saxon, MD, North County Radiology Medial Group Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: October 9, 2007
• First Submitted That Met QC Criteria: October 9, 2007
• First Posted (Estimate): October 10, 2007

Study Record Updates

• Last Update Posted (Estimate): December 27, 2012
• Last Update Submitted That Met QC Criteria: November 26, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Peripheral Vascular Disease; Peripheral Arterial Disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin
• Other Study ID Numbers: VPR 07-03