Evaluating Plaque Photoablation Using an Excimer Laser in Patients With Lower Extremity Vascular Disease

Completed · Not applicable

Conditions studied: Peripheral Arterial Disease

In brief

The purpose of this study is to evaluate the safety and efficacy of an excimer laser in the treatment of patients with lower extremity vascular disease with chronic total occlusions.

Key facts

Study ID

NCT02653456

Run by

Ra Medical Systems

People needed

64

Starts

2016-04-07

Expected to finish

2017-07-14

Last updated by the study team

2018-11-21

Who can join

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

You may qualify if…

• signed informed consent
• symptomatic infrainguinal lower extremity vascular disease (Rutherford category 3, 4, 5 or 6), stable for at least 2 weeks prior to study inclusion
• lesions in the superficial femoral artery (SFA), popliteal, or infrapopliteal arteries at least one angiographically identifiable infrageniculate artery
• patients must be poor surgical candidates, indicated by at least one of the following conditions:
• absence of venous autologous grafts (that is, lack of a suitable vein to use for bypass)
• poor (diffusely diseased or <=1mm diameter) or no distal vessels available for graft anastamosis
• high risk of surgical mortality, evidenced by American Society of Anesthesiologists Physical Class 4 or higher

You may not qualify if…

• age below 18 years
• pregnancy, or plan to become pregnant
• participation in another cardiovascular or peripheral vascular study
• myocardial infarction (MI) in prior month
• stents at treatment site
• disorders or allergies precluding use of radiographic contrast
• renal insufficiency sever enough to contraindicate use of radiographic contrast
• contraindication to treatment with anticoagulants
• untreated ipsilateral iliac stenosis >70%
• inability or unwillingness of the patient to comply with intended examinations
• unavailability of required procedural or imaging equipment
• lesion located in a graft
• hemodynamically significant arrhythmia or left ventricular ejection fraction <20%
• life expectancy less than 6 months
• necrosis necessitating major amputation
• unwillingness of the patient to be anti-coagulated

Where it is running

• California Heart & Vascular Clinic — El Centro, California, United States
• University of California San Diego — San Diego, California, United States
• Merit Health Wesley — Hattiesburg, Mississippi, United States

Full record on ClinicalTrials.gov

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