Evaluation of WIRION™ EPS in Lower Extremities Arteries

Completed · Not applicable

Conditions studied: Peripheral Arterial Disease (PAD)

In brief

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

Key facts

Study ID

NCT02780349

Run by

Gardia Medical

People needed

103

Starts

2016-05-01

Expected to finish

2017-09-30

Last updated by the study team

2018-03-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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