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

Completed · Not applicable

Conditions studied: Peripheral Arterial Disease

In brief

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.

Key facts

Study ID

NCT02923193

Run by

Shockwave Medical, Inc.

People needed

306

Starts

2017-02-22

Expected to finish

2022-06-02

Last updated by the study team

2023-12-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects intended to be treated with the Shockwave Medical Peripheral Lithoplasty® System for de-novo or restenotic lesions of the femoral, ilio-femoral, popliteal, and infra-popliteal arteries.
• Subjects presenting with claudication or CLI by Rutherford Clinical Category 2,3,4,5, or 6 of the target limb.
• Age of subject is > 18.
• Subject or subject's legal representative have been informed of the nature of the study, agrees to participate, and has signed the approved study consent form.
• Calcification is at least moderate, defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending > 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is <50mm in length.

You may not qualify if…

• Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Shockwave Medical Peripheral Lithoplasty® System as per Instructions for Use (IFU) or investigator's opinion.
• Subject is already enrolled in other investigational (interventional) studies that would interfere with study endpoints.

Where it is running

• Stanford Hospital — Palo Alto, California, United States
• Rocky Mountain Regional VA Medical Center — Aurora, Colorado, United States
• UCHealth Northern Colorado — Loveland, Colorado, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• MedStar Cardiovascular Research Network @ Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Tallahassee Research Institute, Inc. — Tallahassee, Florida, United States
• Piedmont Heart Institute — Atlanta, Georgia, United States
• Northeast Georgia Medical Center — Gainesville, Georgia, United States
• Alexian Brothers Medical Center — Elk Grove Village, Illinois, United States
• Advocate Health and Hospitals Corporation — Naperville, Illinois, United States
• Prairie Education & Research Cooperative — Springfield, Illinois, United States
• Midwest Cardiovascular Research Foundation — Davenport, Iowa, United States
• Steward St. Elizabeth's Medical Center — Brighton, Maine, United States
• St. Joseph Mercy Oakland — Pontiac, Michigan, United States
• Ascension / St. John Providence — Southfield, Michigan, United States
• North Mississippi Medical Center — Tupelo, Mississippi, United States
• Saint Luke's Cardiovascular Consultants — Kansas City, Missouri, United States
• St. Luke's East Hospital — Lee's Summit, Missouri, United States
• Deborah Heart and Lung Center — Browns Mills, New Jersey, United States
• Mount Sinai West — New York, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Columbia University Medical Center/New York Presbyterian Hospital — New York, New York, United States
• NC Heart & Vascular Research — Raleigh, North Carolina, United States
• WakeMed Health & Hospitals — Raleigh, North Carolina, United States
• Arkansas Heart Hospital — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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