Evaluation of WIRION™ EPS in Lower Extremities Arteries

Peripheral Arterial Disease (PAD) Clinical Trial

— WISE-LE  

Official title:

Evaluation of WIRION™ EPS in Lower Extremities Arteries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02780349
• Other study ID #: CL-003
• Status: Completed
• Phase: N/A
• First received: May 19, 2016
• Last updated: February 19, 2018
• Start date: May 2016
• Est. completion date: September 30, 2017

Study information

• Verified date: February 2018
• Source: Gardia Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: September 30, 2017
• Est. primary completion date: August 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Arterial Disease (PAD)
• Peripheral Vascular Diseases

Intervention

Device:
• WIRION
Embolic Protection System

Locations

Country	Name	City	State
Germany	Universitats herzzentrum Bad Krozingen	Bad Krozingen
Germany	Universitatklinikum Leipzig	Leipzig
United States	St Elizabeth Medical Center	Boston	Massachusetts
United States	Unity Point	Davenport	Iowa
United States	Denver VA Medical Center	Denver	Colorado
United States	St John Hospital	Detroit	Michigan
United States	Ochsner Clinic	New Orleans	Louisiana
United States	Columbia Presbyterian	New York	New York
United States	Lankenau Institute for Medical Research	Philadelphia	Pennsylvania
United States	Miriam Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Gardia Medical

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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