Amplitude Vascular Systems (AVS) Lithotripsy POWER PAD 2 Trial

NCT06457685 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CL-00005
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 19

Brief 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.

Conditions

Peripheral Arterial Disease (PAD)

Keywords

PAD; Intravascular Lithotripsy; Lithotripsy; IVL; PAD II; PAD 2; Pulse IVL; Pulsatile Lithotripsy

Outcome Measures

Primary Outcomes (2)

• Composite of New Onset Major Adverse Events (MAE)

  MAE defined as experiencing any of the following: • The need for emergency surgical revascularization of target limb * Unplanned target limb amputation (above the ankle) * Symptomatic thrombus or distal emboli, defined as clinical signs or symptoms of thrombus or distal emboli detected in the treated limb in the area of the treated lesion, or distal to the treated lesion, after the index procedure and results in extended hospitalization or noted angiographically, and requiring mechanical or pharmacologic means to improve flow and results in extended hospitalization. * Perforations or dissections of grade D or greater that require an intervention such as bailout stenting.

  Within 30-days of procedure

• Procedural Success

  Defined as: The ability of the Amplitude Vascular System (AVS) Pulse Intravascular Lithotripsy (Pulse IVL) System to achieve a post Pulse IVL residual diameter stenosis of \<50% (after adjunctive therapy, if used) as assessed by quantitative angiography via core lab evaluation.

  Time Frame: Day of procedure

Secondary Outcomes (8)

• Device Success

  Day of procedure

• Clinical Success

  Day of procedure

• Clinically Driven Target Lesion Revascularization

  Within 30 days and six months of procedure

• Patency

  Within 30 days and six months of procedure

• Technical Success

  Day of procedure

Other Outcomes (1)

• Prevalence of post-Pulse IVL Adjudicative Therapy

  Day of procedure

Study Arms (1)

Pulse Intravascular Lithotripsy™ (Pulse IVL™)

EXPERIMENTAL

Pulse Intravascular Lithotripsy™ (Pulse IVL™) to open vessels with calcific walls

Device: Pulse Intravascular Lithotripsy (Pulse IVL)

Interventions

Pulse Intravascular Lithotripsy (Pulse IVL) DEVICE

The Pulse Intravascular Lithotripsy (Pulse IVL) System is used for the treatment of calcified (moderate to severe), stenotic, superficial femoral and popliteal arteries in patients with peripheral arterial disease.

Pulse Intravascular Lithotripsy™ (Pulse IVL™)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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%.

You may not qualify if:

• Candidates will be excluded from the study if any of the following conditions are present:
• Rutherford Clinical Category 0, 1, 5 and 6.
• Active infection in the target leg.
• Planned major amputation of the target leg (transmetatarsal or higher).
• History of prior endovascular or surgical procedure on the target limb within the past 30 days.
• Retrograde pedal/tibial access for intervention.
• Known coagulopathy or has a bleeding diathesis, thrombocytopenia with platelet count \< 100,000/microliter, or International Normalized Ratio (INR) \>1.5.
• Lesion in contralateral limb requiring intervention within the next 30 days.
• Subject contraindicated for antiplatelet, anticoagulant, or thrombolytic therapy.
• Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
• Known allergy to any Pulse IVL product materials.
• Clinically significant myocardial infarction within 60 days prior to enrollment.
• History of stroke within 60 days prior to enrollment.
• History of unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to enrollment.
• History of thrombolytic therapy within two weeks of enrollment.

Sponsors & Collaborators

• Amplitude Vascular Systems, Inc.: lead

Study Sites (19)

Arkansas Heart Hospital

Little Rock, Arkansas, 72022, United States

Location

Vascular and Interventional Specialists of Orange County

Orange, California, 92868, United States

Location

Advanced Heart and Vein Center

Thornton, Colorado, 80023, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52802, United States

Location

Mercy Hospital South

St Louis, Missouri, 63128, United States

Location

Advanced Endovascular Physicians

West Orange, New Jersey, 07052, United States

Location

NYU Langone

New York, New York, 10016, United States

Location

Mount Sinai

New York, New York, 10029, United States

Location

Columbia University and New York Presbyterian Hospital (NYPH)

New York, New York, 10032, United States

Location

NC Heart and Vascular Research

Raleigh, North Carolina, 27607, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

University Hospital- Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

OhioHealth Riverside

Columbus, Ohio, 43214, United States

Location

Mainline Health Lankenau

Bryn Mawr, Pennsylvania, 19010, United States

Location

UPMC Pinnacle

Mechanicsburg, Pennsylvania, 17050, United States

Location

The Miriam Hospital - Brown University Health Partner

Providence, Rhode Island, 02906, United States

Location

Ascension Seton

Austin, Texas, 78723, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Christopher Metzger, MD

  Ohio Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 13, 2024
• Study Start: September 5, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

US (19)