Peripheral Arterial Disease (PAD) Clinical Trial
Official title:
Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Peripheral Artery Disease
POWER PAD 2 is a prospective, single-arm, multicenter, non-randomized clinical study designed to demonstrate the safety and effectiveness of the Amplitude Vascular Systems (AVS) Pulse Intravascular Lithotripsy™ (Pulse IVL™) System for treatment of calcified (moderate to severe), stenotic, superficial femoral and popliteal arteries in patients with peripheral arterial disease.
POWER PAD 2 is a prospective, single-arm, multicenter, non-randomized clinical study designed to demonstrate the safety and effectiveness of the Amplitude Vascular System (AVS) Pulse Intravascular Lithotripsy™ (Pulse IVL™) System for treatment of calcified (moderate to severe), stenotic, superficial femoral and popliteal arteries in patients with peripheral arterial disease. This study will enroll subjects >18 years old that are presenting for a peripheral arterial disease intervention for the treatment of peripheral artery disease. Specifically, the subject has moderate to heavily calcified superficial femoral and popliteal arteries, presenting with Rutherford Category 2 to 4 of the target limb, with a reference vessel diameter (RVD) of 4mm to 6.5mm and a total lesion length of ≤ 150mm. Up to 120 subjects will be treated in the study at up to 20 U.S. investigational sites. Subjects will be evaluated at discharge, 30 days and 6 months after procedure. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT01175850 -
Randomized Trial of IN.PACT Admiral® Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease
|
N/A | |
| Active, not recruiting |
NCT00707876 -
Magnetic Resonance Angiography for Peripheral Arterial Disease (PAD)
|
Phase 2 | |
| Completed |
NCT00760565 -
A Multiple Ascending Dose Study of RO4905417 in Healthy Volunteers and Patients With Peripheral Arterial Disease (PAD).
|
Phase 1 | |
| Recruiting |
NCT04631848 -
ULTRASCORE™ Focused Force PTA Balloon Angioplasty for CLI Patients With Below the Knee Vessel Disease
|
||
| Completed |
NCT00196066 -
Evaluation of the Zilver Vascular Stent in the Iliac Arteries (ZIPS)
|
Phase 2 | |
| Recruiting |
NCT05834673 -
VICTORION-ASCERTAIN: Implementation Study (v-ASCERTAIN)
|
Phase 4 | |
| Recruiting |
NCT05498740 -
Post-marketing Study in Femoral Popliteal Artery of Drug Coated Balloon Used for Treatment of Lower Limb Ischemia
|
N/A | |
| Completed |
NCT02780349 -
Evaluation of WIRION™ EPS in Lower Extremities Arteries
|
N/A | |
| Completed |
NCT02254837 -
Zilver PTX Post-Market Study in Japan
|
N/A | |
| Completed |
NCT02254356 -
Zilver Flex Post-Market Study in Japan
|
N/A | |
| Completed |
NCT00689377 -
Prevalence of Peripheral Arterial Disease in Subject With a Moderate Risk of Cardiovascular (CV) Disease (CVD) in Primary Prevention
|
N/A | |
| Active, not recruiting |
NCT05149664 -
A Non-significant Risk Clinical Study: Changes in Perfusion After Therapeutic Ultrasound in Patients With PAD
|
N/A | |
| Recruiting |
NCT04749732 -
Home-based Exercise Therapy for Patients With PAD
|
N/A | |
| Completed |
NCT02936622 -
Paclitaxel-coated Peripheral Stents Used in the Treatment of Femoropopliteal Stenoses
|
N/A | |
| Completed |
NCT00827619 -
Zilver® Flex™ Vascular Stent Study
|
N/A | |
| Completed |
NCT00862420 -
Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease
|
Phase 3 | |
| Completed |
NCT04753372 -
Rivaroxaban Plus Aspirin in Patients With Chronic Coronary Syndrome and High Ischemic Risk
|
||
| Recruiting |
NCT05246410 -
A Clinical Trial to Evaluate the Efficacy and Safety of a Spot Stent System Used in Femoropopliteal Arteries.
|
N/A | |
| Terminated |
NCT03111238 -
The Efficacy and Safety of REX-001 to Treat Ischemic Rest Pain in Subjects With CLI Rutherford Category 4 and DM
|
Phase 3 | |
| Terminated |
NCT03174522 -
The Efficacy and Safety of REX-001 to Treat Ischemic Ulcers in Subjects With CLI Rutherford Category 5 and DM
|
Phase 3 |