Femoropopliteal In-Stent Restenosis
Conditions
Keywords
ISR, Laser, SFA, PAD
Brief summary
The study will evaluate the procedural safety and efficacy of the Winsor Laser Catheters for the treatment of In-Stent Restenosis (ISR) in the Superficial Femoral Artery (SFA)
Interventions
DEVICEWinsor Laser Catheter
Sponsors
Yale University
Spectranetics Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patient age ≥ 18 years. 2. Rutherford Category 2-4. 3. Subject has been informed of the nature of the study, agrees to participate and has signed an Ethics Committee approved informed consent form. 4. Documentation of significant ISR defined as \>50% stenosis and \>5 cm in length determined by diagnostic angiogram or duplex ultrasound. 5. A previously deployed bare nitinol stent(s) in the femoropopliteal segment extending from the ostium of the SFA to 1 cm above the tibioperoneal trunk. A guidewire has successfully traversed the target treatment segment, or is able to cross using standard support catheter crossing techniques, is angiographically documented to be within true lumen and not placed through stent struts. Guidewire access may obtained via contralateral, ipsilateral or retrograde approach. If a retrograde guidewire approach is used to cross the target lesion, guidewire exchange and an antegrade approach is required prior to treatment with the Winsor Laser Catheter. 6. One or more patent tibial vessel(s) defined as \<50% stenosis thoughout the segment with outflow to the foot. 7. Successful treatment of any inflow lesion(s) defined as final residual stenosis \<30%.
Exclusion criteria
1. Patient is pregnant. 2. Has known uncontrollable hypercoagulable condition, or refuses blood transfusion. 3. Any co-morbid condition that in the judgment of the physician precludes safe percutaneous intervention. 4. Crossing devices other than guidewire support catheters. 5. Type 4 or 5 stent fracture as assessed by angiography. 6. Target lesion is located within a covered stent. 7. Acute limb ischemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint | up to 48 hours | Freedom from Major Adverse Events (MAE) through hospital discharge: * All-cause peri-procedural death * Target limb amputation (above or below the ankle) * Target limb re-intervention * Target limb-related death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | During Interventional Procedure | Procedural success defined as the percent of target lesions that achieve ≤30% residual stenosis at the completion of the procedure (laser atherectomy and any adjunctive treatment) as determined by an independent angiographic core lab. |
Countries
Colombia
Outcome results
None listed