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

Stopped early · Not applicable

Conditions studied: Peripheral Vascular Disease

In brief

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).

Key facts

Study ID: NCT00902317
Run by: Arizona Heart Institute
People needed: 130
Starts: 2004-11-01
Expected to finish: 2009-05-01
Last updated by the study team: 2009-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Stenosis > 70% or total occlusion of the femoropopliteal segment that do not include the origin of the SFA.
SFA and popliteal of > 4 mm in diameter.
TASC classification A, B, and C.
At least one vessel run-off.

You may not qualify if…

Age < 18 years old.
Medical condition that may cause the patient not to be compliant with follow-up (Ex. terminal cancer).
Pregnancy
Unwilling or unable to comply with the follow-up.
Inability or refusal of informed consent.
Medical Exclusion Criteria:
Systemic Infection (sepsis)
Bleeding diathesis unable to use anticoagulation.
Untreatable reaction to contrast material.
Anatomical Endovascular Exclusion Criteria:
SFA/Popliteal artery < 4 mm diameter.
Total occlusion of femoral artery with non-visualization of the origin of the SFA.
Previous SFA/popliteal intervention (PTA, stenting etc.)
Acute ischemia and/or acute thrombosis of the SFA-Popliteal segment.
TASC type D.

Where it is running

Arizona Heart Institute — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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