Evaluating Plaque Photoablation Using an Excimer Laser in Patients With Lower Extremity Vascular … (NCT02653456) | Clinical Trial Compass
CompletedNot Applicable
Evaluating Plaque Photoablation Using an Excimer Laser in Patients With Lower Extremity Vascular Disease
United States64 participantsStarted 2016-04-07
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 le…