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

Femoropopliteal In-Stent Restenosis Clinical Trial

Official title:

First in Human Study of Winsor Laser Catheter

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01962389
• Other study ID #: Winsor - 001
• Status: Withdrawn
• Phase: Phase 1
• First received: October 7, 2013
• Last updated: December 4, 2014
• Start date: January 2014

Study information

• Verified date: December 2014
• Source: Spectranetics Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosColombia: National Institutes of Health
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Femoropopliteal In-Stent Restenosis

Intervention

Device:
• Winsor Laser Catheter

Locations

Country	Name	City	State
Colombia	Centro Cardiovascular Colombiano	Medellin

Sponsors (2)

Lead Sponsor	Collaborator
Spectranetics Corporation	Yale University

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety Endpoint	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	up to 48 hours	Yes
Secondary	Efficacy	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.	During Interventional Procedure	No