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Endoprosthesis
GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER) (VIPER Trial)
N/A
Waitlist Available
Led By Richard Saxon, MD
Research Sponsored by W.L.Gore & Associates
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Peripheral Vascular Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Primary Patency at 12 Months
Secondary study objectives
Device-related Major Adverse Events at 12 Months
Primary Assisted Patency
Proportion of Subjects Who Experience Major Device-related Adverse Events Within the First 30 Days
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: GORE VIABHAN EndoprothesisExperimental Treatment1 Intervention
Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
2007
N/A
~120
Find a Location
Who is running the clinical trial?
W.L.Gore & AssociatesLead Sponsor
100 Previous Clinical Trials
32,670 Total Patients Enrolled
Richard Saxon, MDPrincipal InvestigatorNorth County Radiology Medial Group Inc.
1 Previous Clinical Trials
85 Total Patients Enrolled