CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 148 enrolled
Drug / intervention
GORE VIABAHN Endoprosthesis +1 moredevice
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Lifestyle-limiting claudication or rest pain
  • ✓At least 21 years of age
  • ✓Projected life expectancy of greater than three years
  • ✓Quality of life questionnaires completed
Key exclusion· 10
  • ✕Any previous stenting or surgery in the target vessel
  • ✕Untreated flow-limiting aortoiliac occlusive disease
  • ✕Severe ipsilateral common femoral/profunda disease requiring surgical intervention
  • ✕Femoral or popliteal aneurysm

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00228384
NCT00228384Phase 4Completed
CompareCT.gov

GORE VIABAHN Endoprosthesis Versus Bare Nitinol Stent in the Treatment of Long Lesion (>8cm) Superficial Femoral Artery Occlusive Disease

W.L.Gore & Associates·interventional·Posted Sep 28, 2005·Updated Jun 4, 2012

In Brief

A Phase 4 clinical trial evaluating GORE VIABAHN Endoprosthesis and Bare Nitinol Stent for Peripheral Vascular Diseases. Completed, enrolled 148 participants across 15 sites.

Detailed Summary

To evaluate the performance of the GORE VIABAHN® Endoprosthesis compared to a bare nitinol stent for the treatment of superficial femoral artery (SFA) occlusive disease in long lesions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Vascular Diseases
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 28, 2005
Enrollment StartSep 1, 2005
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 20.8 years ago

Interventions

GORE VIABAHN Endoprosthesisdevice

Implantation

Bare Nitinol Stentdevice

Implantation