Excellence in Peripheral Arterial Disease Treatment of Superficial Femoral Artery Disease With Drug-eluting Stents

Stopped early · Not applicable

Conditions studied: Peripheral Vascular Diseases, Chronic Total Occlusion of Artery of the Extremities

In brief

The superficial femoral artery (SFA) is frequently involved in atherosclerosis and is the most common target of lower extremity endovascular procedures performed in patients with claudication. Endovascular treatment of SFA is challenging, given its exceptional predisposition to atherosclerosis and its exposure to extreme mechanical forces of extension, compression, torsion and flexion. The SFA is located in a fibro-muscular canal, follows a tortuous course and is considered a 'hostile' location for endovascular procedures, especially stents due to the risk of stent fracture. On the other hand, durability of balloon angioplasty in the SFA is dismal (25% patency at 1 year). Therefore, Nitinol (a metal alloy of nickel and titanium) stent implantation is the mainstay of endovascular SFA interventions when balloon angioplasty (PTA) leads to sub-optimal results during a procedure. It is used in over 70% of all cases and in nearly 100% of all femoro-popliteal (FP) CTO (chronic total occlusions) and long (≥60 mm) interventions. Endovascular treatment of SFA is challenging and restenosis is the most common cause for the lack of durability of a SFA peripheral vascular interventional procedure.5 Restenosis rates of SFA bare metal (nitinol) stents or BMS at 1 year exceeds 50% for lesions ≥60 mm in length or CTO. Stent based treatment of the SFA may not offer any additional advantage for short non-CTO (\<60 mm) lesions compared to PTA. In a recent study, primarily comparing drug-eluting stents (DES) to balloon angioplasty in the SFA, 12 month patency rates were 83.1% and 32.8%, respectively for DES and balloon angioplasty arms. However, there are no head-to head studies randomized studies comparing DES and BMS in the SFA. Thus, endovascular SFA intervention in patients with symptomatic PAD is an area of urgent need for high-quality evidence as volume of these procedures continues to rise exponentially in the U.S. and around the world, largely on the basis of insufficient evidence.Thus, the purpose of this study is to conduct a randomized pilot trial comparing DES and BMS for percutaneous revascularization of SFA.

Key facts

Study ID: NCT03671655
Run by: North Texas Veterans Healthcare System
People needed: 4
Starts: 2014-01-01
Expected to finish: 2015-08-31
Last updated by the study team: 2018-09-14

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age 18 years or older
Referred for clinically indicated lower extremity angiography and peripheral arterial intervention
Willing and able to give informed consent. The patients must be able to comply with study procedures and follow-up.
Absence of allergy to both clopidogrel and aspirin
Negative pregnancy test or breast-feeding
No coexisting conditions that limit life expectancy to less than 12 months or that could affect a patient's compliance with the protocol as per the site investigator
Serum creatinine <2.5 mg/dL
Baseline hemoglobin >9 g/dl
Baseline platelet count >80,000/L
Absence of prior stroke or transient ischemic attack within 3 months
≥30 days from any prior surgical or endovascular procedure
Angiographic enrollment criteria:
Undergoing SFA revascularization with the intention for stent implantation
De novo SFA lesion ≥60 mm in length by visual estimation
Successfully crossed de novo SFA CTO of any length by visual estimation

You may not qualify if…

SFA lesion involving <5mm of ostial SFA and/or profunda femoris artery take-off
SFA lesion extending below the medial femoral epicondyle
<1 vessel below-the knee (BTK) run-off

Where it is running

North Texas Veterans Affairs Health Care System — Dallas, Texas, United States
University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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