Evaluation of WIRION™ EPS in Lower Extremities Arteries (WISE-LE)

Demonstrate the safety and performance of the WIRION™ EPS in subjects undergoing lower extremity atherectomy for the treatment of Peripheral Arterial Disease (PAD)

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease (PAD)
• Intervention / Treatment: Device: WIRION

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bad Krozingen, Germany, 79189
    • Universitats Herzzentrum Bad Krozingen
  • Leipzig, Germany, 04103
    • Universitätklinikum Leipzig
• United States
  • Colorado
    • Denver, Colorado, United States, 80220
      • Denver VA Medical Center
  • Iowa
    • Davenport, Iowa, United States
      • Unity Point
  • Louisiana
    • New Orleans, Louisiana, United States
      • Ochsner Clinic
  • Massachusetts
    • Boston, Massachusetts, United States, 02135
      • St Elizabeth Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48236
      • St John Hospital
  • New York
    • New York, New York, United States
      • Columbia Presbyterian
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19096
      • Lankenau Institute for Medical Research
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Miriam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject is at least 18 years of age
2. Subject or authorized representative, signed a written Informed Consent form to participate in the study, prior to any study related procedures
3. Subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations
4. Rutherford classification 2-4
5. Has moderate to severe calcification visualized on angiogram in the femoropopliteal arteries
6. Planned atherectomy of the native femoropopliteal arteries
7. Reference vessel diameter for intended filter location must be visually estimated to be ≥3.5mm and ≤6.0mm
8. An adequate "landing zone" for placement of the WIRION™ device distal to the target lesion of at least 30mm
9. A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days and agrees to remain on birth control throughout the study

Exclusion Criteria:

1. Any planned surgical or endovascular intervention within 30 days before or after the index procedure
2. A lesion deemed not accessible by the WIRION™ EPS
3. Inability to take aspirin or ADP receptor antagonists
4. History of bleeding diathesis or coagulopathy or will refuse blood transfusion if deemed necessary
5. Has perforation, dissection, or other injury of the access or target vessel requiring additional stenting or surgical intervention before enrollment
6. Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint (participating in registry studies is not excluded)
7. Life expectancy less than 12 months
8. Known severe renal insufficiency (eGFR <30 ml/min/1.72m2).
9. ≤1-vessel tibial run-off status

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WIRION EPS; Single arm study. All patients undergo procedure with the WIRION EPS	Device: WIRION; Embolic Protection System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom From Major Adverse Events (MAE) to 30 Days Post Procedure.	MAE defined as a serious adverse event that results in death, acute myocardial infarction, thrombosis, pseudo-aneurysm, dissection (grade C or greater) or clinical perforation at the filter location, distal embolism (clinically relevant), unplanned amputation, or clinically-driven target vessel revascularization (TVR), through 30 days post-procedure, as adjudicated by the Clinical Events Committee (CEC)	30 days

Collaborators and Investigators

• Sponsor: Gardia Medical
• Investigators: Principal Investigator: William Gray, MD, Main Line Health

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): August 30, 2017
• Study Completion (Actual): September 30, 2017

Study Registration Dates

• First Submitted: May 19, 2016
• First Submitted That Met QC Criteria: May 19, 2016
• First Posted (Estimate): May 23, 2016

Study Record Updates

• Last Update Posted (Actual): March 15, 2018
• Last Update Submitted That Met QC Criteria: February 19, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: CL-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No