Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III)

Recruiting in Palo Alto (17 mi)

+56 other locations

Overseen byGunnar Tepe, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Shockwave Medical, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind, randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard balloon angioplasty used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries. Assuming that roughly 15% of the subjects will be lost-to-follow-up, a total of up to 400 subjects (200 per treatment arm) will be enrolled in the study at up to 60 sites in Europe, the United States and New Zealand. In addition to the randomized study, an observational study of subjects who do not meet the inclusion/exclusion criteria for the randomized study will be conducted. The objective of the observational study is to assess the real-world acute performance of the Shockwave Medical Peripheral Lithoplasty System in the treatment of calcified, stenotic, peripheral arteries. The observational study is a prospective, multi-center, single arm observational study for subjects who do not meet the inclusion/exclusion criteria of the randomized study. A maximum of 1500 subjects at the same 60 sites will be enrolled in the observational study. Once enrollment in the randomized portion of the study is complete, subjects may continue to be enrolled in the observational study provided they meet OS eligibility criteria. Results for the observational study will be reported in a separate record under NCT05881421.

Eligibility Criteria

Inclusion Criteria

Randomized Study Arm Eligibility Criteria

General Inclusion Criteria

Subject is able and willing to comply with all assessments in the study.

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Treatment Details

Interventions

Medtronic IN.PACT (DCB) (Drug)
Shockwave Lithoplasty® Peripheral Lithoplasty System (Device)

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Lithoplasty System followed by DCBExperimental Treatment2 Interventions

Shockwave Lithoplasty® Peripheral Lithoplasty System is a lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic peripheral arteries in patients who are candidates for percutaneous therapy. lithoplasty

Group II: Medtronic IN.PACT (DCB)Active Control1 Intervention

Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease.