Peripheral Arterial Disease (PAD)
Conditions
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)
Interventions
DEVICEWIRION
Embolic Protection System
Sponsors
Gardia Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Major Adverse Events (MAE) to 30 Days Post Procedure. | 30 days | 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) |
Countries
Germany, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm WIRION: Embolic Protection System | 103 |
| Total | 103 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Continuous | 68.2 years STANDARD_DEVIATION 9.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 93 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment Germany | 24 participants |
| Region of Enrollment United States | 79 participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 103 |
| other Total, other adverse events | 9 / 103 |
| serious Total, serious adverse events | 8 / 103 |
Outcome results
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)
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Freedom From Major Adverse Events (MAE) to 30 Days Post Procedure. | 2 Participants |