Clinical trial NCT02780349: Evaluation of WIRION™ EPS in Lower Extremities Arteries
Official title: Evaluation of WIRION™ EPS in Lower Extremities Arteries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease (PAD)
Lead sponsor: Gardia Medical
Sponsor class: INDUSTRY
First posted: 2016-05-23
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)


Eligibility criteria: 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

Primary outcomes:
measure: Freedom From Major Adverse Events (MAE) to 30 Days Post Procedure.
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver VA Medical Center
state: Colorado
city: Davenport
country: United States
facility: Unity Point
state: Iowa
city: New Orleans
country: United States
facility: Ochsner Clinic
state: Louisiana
city: Boston
country: United States
facility: St Elizabeth Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: St John Hospital
state: Michigan
city: New York
country: United States
facility: Columbia Presbyterian
state: New York
city: Philadelphia
country: United States
facility: Lankenau Institute for Medical Research
state: Pennsylvania
city: Providence
country: United States
facility: Miriam Hospital
state: Rhode Island
city: Bad Krozingen
country: Germany
facility: Universitats herzzentrum Bad Krozingen
city: Leipzig
country: Germany
facility: Universitatklinikum Leipzig
Study officials:
affiliation: Main Line Health
name: William Gray, MD
role: PRINCIPAL_INVESTIGATOR
References: