CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 86 enrolled
Drug / intervention
Femoral-popliteal Bypass +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00693823
NCT00693823N/ACompleted

A Prospective Randomized Comparison of Prosthetic Femoropopliteal Bypass Versus Viabahn Endoprosthesis for Treatment of Symptomatic Superficial Femoral Artery Occlusion

Texas Vascular Associates·interventional·Posted Jun 9, 2008·Updated Jun 9, 2008

In Brief

A clinical study evaluating Femoral-popliteal Bypass and Angioplasty and stent placement with Viabahn covered stent-graft(W.L. Gore & Associates, Flagstff, Arizona) of superficial femoral artery for Atherosclerosis and 3 related conditions. Completed, enrolled 86 participants across 1 site.

Detailed Summary

This study is a comparison of two different ways to treat blockage in the artery of the thigh. The first is an older way with incisions in the groin and just above the knee. A plastic tube is then inserted to make a bypass from the groin to the knee. The second treatment offered is through a needle hole in the groin. A thin plastic tube covering a metal stent is inserted into the artery and released to bypass the blockage from inside the artery. No incisions are needed. Patients are enrolled and then selected for one treatment method or another by chance. The patients will be followed for two years to see how the two different treatment methods work compared to each other.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 9, 2008
Enrollment StartSep 1, 2003
Primary CompletionMay 1, 2007
Study CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 18.1 years ago

Interventions

Femoral-popliteal Bypassprocedure

Surgical placement of a prosthetic graft in the thigh from the groin to the knee

Angioplasty and stent placement with Viabahn covered stent-graft(W.L. Gore & Associates, Flagstff, Arizona) of superficial femoral arterydevice

Placement of an ePTFE covered stent graft within the superficial femoral artery in the thigh through a needle hole percutaneously