Back to resultsGORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER) (VIPER)
Primary Purpose
Peripheral Vascular Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Vascular Diseases focused on measuring Peripheral Arterial Disease, Peripheral Vascular Disease
Eligibility 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
Sites / Locations
- Tri-City Medical Center
- Mercy Hospital and Medical Center
- Columbia Surgical Associates
- Baylor University Medical Center
- St. Luke's Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GORE VIABHAN Endoprothesis
Arm Description
Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT00541307
First Posted
October 9, 2007
Last Updated
November 26, 2012
Sponsor
W.L.Gore & Associates
1. Study Identification
Unique Protocol Identification Number
NCT00541307
Brief Title
GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER)
Acronym
VIPER
Official Title
Post Marketing Study of the GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease (VIPER)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
W.L.Gore & Associates
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Diseases
Keywords
Peripheral Arterial Disease, Peripheral Vascular Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GORE VIABHAN Endoprothesis
Arm Type
Experimental
Arm Description
Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
Intervention Type
Device
Intervention Name(s)
Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
Intervention Description
Endovascular treatment of the study lesion with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
Primary Outcome Measure Information:
Title
Primary Patency at 12 Months
Description
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 Outcome Measure Information:
Title
Proportion of Subjects Who Experience Major Device-related Adverse Events Within the First 30 Days
Description
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
Title
Primary Assisted Patency
Description
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
Title
Secondary Patency
Description
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
Title
Device-related Major Adverse Events at 12 Months
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Saxon, MD
Organizational Affiliation
North County Radiology Medial Group Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tri-City Medical Center
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Mercy Hospital and Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Columbia Surgical Associates
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States
12. IPD Sharing Statement
Learn more about this trial
GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER)
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