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

Primary Purpose

Peripheral Arterial Disease (PAD)

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
WIRION
Sponsored by
Gardia Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease (PAD)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Denver VA Medical Center
  • Unity Point
  • Ochsner Clinic
  • St Elizabeth Medical Center
  • St John Hospital
  • Columbia Presbyterian
  • Lankenau Institute for Medical Research
  • Miriam Hospital
  • Universitats herzzentrum Bad Krozingen
  • Universitatklinikum Leipzig

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

WIRION EPS

Arm Description

Single arm study. All patients undergo procedure with the WIRION EPS

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
May 19, 2016
Last Updated
February 19, 2018
Sponsor
Gardia Medical
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1. Study Identification

Unique Protocol Identification Number
NCT02780349
Brief Title
Evaluation of WIRION™ EPS in Lower Extremities Arteries
Acronym
WISE-LE
Official Title
Evaluation of WIRION™ EPS in Lower Extremities Arteries
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
August 30, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gardia Medical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease (PAD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WIRION EPS
Arm Type
Experimental
Arm Description
Single arm study. All patients undergo procedure with the WIRION EPS
Intervention Type
Device
Intervention Name(s)
WIRION
Intervention Description
Embolic Protection System
Primary Outcome Measure Information:
Title
Freedom From Major Adverse Events (MAE) to 30 Days Post Procedure.
Description
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)
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is at least 18 years of age Subject or authorized representative, signed a written Informed Consent form to participate in the study, prior to any study related procedures Subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations Rutherford classification 2-4 Has moderate to severe calcification visualized on angiogram in the femoropopliteal arteries Planned atherectomy of the native femoropopliteal arteries Reference vessel diameter for intended filter location must be visually estimated to be ≥3.5mm and ≤6.0mm An adequate "landing zone" for placement of the WIRION™ device distal to the target lesion of at least 30mm 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: Any planned surgical or endovascular intervention within 30 days before or after the index procedure A lesion deemed not accessible by the WIRION™ EPS Inability to take aspirin or ADP receptor antagonists History of bleeding diathesis or coagulopathy or will refuse blood transfusion if deemed necessary Has perforation, dissection, or other injury of the access or target vessel requiring additional stenting or surgical intervention before enrollment Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint (participating in registry studies is not excluded) Life expectancy less than 12 months Known severe renal insufficiency (eGFR <30 ml/min/1.72m2). ≤1-vessel tibial run-off status
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Gray, MD
Organizational Affiliation
Main Line Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denver VA Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Unity Point
City
Davenport
State/Province
Iowa
Country
United States
Facility Name
Ochsner Clinic
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
St Elizabeth Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
St John Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Columbia Presbyterian
City
New York
State/Province
New York
Country
United States
Facility Name
Lankenau Institute for Medical Research
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Universitats herzzentrum Bad Krozingen
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Universitatklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of WIRION™ EPS in Lower Extremities Arteries

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