Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Peripheral Artery Disease

Status: Recruiting
Location: See all (20) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Candidates will be included in the study only if all of the following conditions are met:

• Able and willing to comply with all assessments in the study.

• Subject or subject's legal representative have been informed of the nature of the study, agrees to participate, and has signed the approved consent form.

• \>18 years old

• Rutherford Clinical Category 2, 3, or 4 of the target limb

• Resting ankle-brachial index (ABI) of ≤0.90, or ≤0.75 after exercise, of the target leg OR ≥70% stenosis by prior imaging (CT/MR angiogram, DUS).

• Subjects has de novo lesions who are felt to have indication for peripheral angiography and endovascular intervention by the investigator per their standard of care.

• Estimated life expectancy \>1 year, in the opinion of the investigator at the time of screening.

⁃ Angiographic Inclusion Criteria

⁃ Candidates will be included in the study only if all of the following intraoperative conditions are met:

• Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guideline.

• Target lesion that is located in a native de novo superficial femoral artery (SFA) or popliteal artery (popliteal artery extends to 2 cm above the bifurcation, or trifurcation, of the tibial artery).

• Target lesion reference vessel diameter is between 4.0 mm and 6.5 mm by visual estimate.

• Target zone is ≤ 150 mm in total contiguous treatable length. Target lesion can be all or part of the 150 mm zone.

• Target lesion is ≥70% stenosis via visual estimate.

• Subject has at least one patent tibial vessel on the target leg with runoff to the ankle (not supported by collateral circulation.) Tibial vessel patency is defined as no stenosis \>50%.

• Ability to pass the guidewire across the atherosclerotic lesion, without the use of re-entry devices.

• No evidence of aneurysm or acute or chronic thrombus in target vessel.

• Calcification is at least moderate. (Presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending ≥ 50% the length of the lesion.)

Locations
United States
Arkansas
Arkansas Heart Hospital
RECRUITING
Little Rock
California
Vascular and Interventional Specialists of Orange County
RECRUITING
Orange
Colorado
Advanced Heart and Vein Center
RECRUITING
Thornton
Georgia
Piedmont Heart Institute
RECRUITING
Atlanta
Iowa
Midwest Cardiovascular Research Foundation
RECRUITING
Davenport
Missouri
Mercy Hospital South
RECRUITING
St Louis
North Carolina
NC Heart and Vascular Research
RECRUITING
Raleigh
New Jersey
Holy Name Medical Center
WITHDRAWN
Teaneck
Advanced Endovascular Physicians
RECRUITING
West Orange
New York
Columbia University and New York Presbyterian Hospital (NYPH)
RECRUITING
New York
Mount Sinai
RECRUITING
New York
NYU Langone
RECRUITING
New York
Ohio
The Christ Hospital
RECRUITING
Cincinnati
University Hospital- Cleveland Medical Center
RECRUITING
Cleveland
OhioHealth Riverside
RECRUITING
Columbus
Pennsylvania
Mainline Health Lankenau
NOT_YET_RECRUITING
Bryn Mawr
UPMC Pinnacle
RECRUITING
Mechanicsburg
Rhode Island
The Miriam Hospital - Brown University Health Partner
RECRUITING
Providence
Texas
Ascension Seton
RECRUITING
Austin
The Heart Hospital Baylor Plano
RECRUITING
Plano
Contact Information
Primary
Beatriz Vendrell-Velez
bvendrell-velez@avspulse.com
210-414-2646
Backup
Elizabeth Galle
liz.galle@avspulse.com
754.755.1530
Time Frame
Start Date: 2024-09-05
Estimated Completion Date: 2026-03
Participants
Target number of participants: 120
Treatments
Experimental: Pulse Intravascular Lithotripsy™ (Pulse IVL™)
Pulse Intravascular Lithotripsy™ (Pulse IVL™) to open vessels with calcific walls
Sponsors
Leads: Amplitude Vascular Systems, Inc.

This content was sourced from clinicaltrials.gov