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

First in Human Study of Winsor Laser Catheter

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)

Study Overview

• Status: Withdrawn
• Conditions: Femoropopliteal In-Stent Restenosis
• Intervention / Treatment: Device: Winsor Laser Catheter

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• Colombia
  • Medellin, Colombia
    • Centro Cardiovascular Colombiano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Winsor Laser Catheter	Device: Winsor Laser Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Spectranetics Corporation
• Collaborators: Yale University

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ANTICIPATED): April 1, 2014

Study Registration Dates

• First Submitted: October 7, 2013
• First Submitted That Met QC Criteria: October 9, 2013
• First Posted (ESTIMATE): October 14, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 8, 2014
• Last Update Submitted That Met QC Criteria: December 4, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: ISR, Laser, SFA, PAD
• Other Study ID Numbers: Winsor - 001