First in Human Study of Winsor Laser Catheter: A Prospective Registry to Evaluate The Safety and Performance of the Winsor Laser Catheter in the Treatment of In-Stent Restenosis

Spectranetics

Status and phase: Withdrawn; Phase 1

Conditions: Femoropopliteal In-Stent Restenosis

Treatments: Device: Winsor Laser Catheter

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01962389

Winsor - 001

Details and patient eligibility

About

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)

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Winsor Laser Catheter

Experimental group

Treatment:

Device: Winsor Laser Catheter