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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT00541307
First received: October 9, 2007
Last updated: November 26, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Peripheral Vascular Diseases
Device: Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Post Marketing Study of the GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease (VIPER)

Resource links provided by NLM:


Further study details as provided by W.L.Gore & Associates:

Primary Outcome Measures:
  • Primary Patency at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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:
  • Proportion of Subjects Who Experience Major Device-related Adverse Events Within the First 30 Days [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 119
Study Start Date: October 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00541307

Locations
United States, California
Tri-City Medical Center
Oceanside, California, United States, 92056
United States, Illinois
Mercy Hospital and Medical Center
Chicago, Illinois, United States, 60616
United States, Missouri
Columbia Surgical Associates
Columbia, Missouri, United States, 65201
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75226
United States, Wisconsin
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53233
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
Principal Investigator: Richard Saxon, MD North County Radiology Medial Group Inc.
  More Information

No publications provided

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00541307     History of Changes
Other Study ID Numbers: VPR 07-03
Study First Received: October 9, 2007
Results First Received: June 22, 2012
Last Updated: November 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by W.L.Gore & Associates:
Peripheral Arterial Disease
Peripheral Vascular Disease

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Calcium heparin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 16, 2014