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Prime Time for Superficial Femoral Artery (SFA) - The SFA Study

NCT00902317 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2009-05-15

No results posted yet for this study

Summary

The purpose of this study is to compare the different endovascular treatment modalities for the femoropopliteal segment, and to determine technical success, efficacy and patency at mid-term follow-up. Modalities include; Angioplasty/stent (Control group, Guidant), Cryoplasty/stent (Boston Scientific), Laser Angioplasty/stent (Spectranetics), SilverHawk Atherectomy/stent (Fox Hollow), and Viabahn Endograft (WL Gore).

Conditions

  • Peripheral Vascular Disease

Interventions

PROCEDURE

Cryoplasty (PolarCath peripheral balloon catheter)

Cryoplasty involves advancing the balloon catheter to the site of the lesion and delivering liquid nitrous oxide into the balloon, where it expands into gas and inflates the balloon.

PROCEDURE

Laser Angioplasty (Spectranetics)

The basic concept of laser angioplasty is to apply light energy directly to the arterial plaque, thereby altering the plaque in some helpful way, without damaging the surrounding artery.

PROCEDURE

SilverHawk Atherectomy

Once the catheter is connected to the cutter driver, by retracting the positioning lever this simultaneously turns on the motor and caused the distal portion of the cutter housing to deflect, forcing the device against the target lesion.

DEVICE

Viabahn Endograft

The Gore-Viabahn should be positioned across the target lesion using the radiopaque hub and tip markers on the catheter. These markers identify the proximal and distal ends of the device, respectively.

PROCEDURE

Angioplasty/Stent (Guidant "Absolute" stent)

A Stent is a metal scaffold that is also delivered by a catheter and positioned through the narrowing in the artery. The stent is then expanded against the wall of the blood vessel to provide a wider channel for blood flow. The stent remains implanted in the blood vessel, and after a few weeks, the inner lining of the blood vessel will grow over the stent surface.

Sponsors & Collaborators

  • Arizona Heart Institute

    lead OTHER

Principal Investigators

  • Julio Rodriguez-Lopez, M.D. · Arizona Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00902317 on ClinicalTrials.gov