DISRUPT PAD III Observational Study

Completed

Conditions studied: Peripheral Arterial Disease

In brief

The Disrupt PAD III study was designed as a randomized controlled trial (RCT) with an additional observational registry component. The registry, referred to as the Disrupt PAD III Observational Study (PAD III OS), was a global, prospective, multi-center, single-arm registry of the Shockwave Peripheral Intravascular Lithotripsy (IVL) System. The objective of this study was to assess the real-world acute performance of IVL in the treatment of calcified, stenotic, peripheral arteries that may not qualify for inclusion in the RCT. The study was designed to enroll a maximum of 1500 subjects from up to 60 global sites with a minimum of 200 subjects treated with the S4 IVL catheter, a line extension designed to treat smaller diameter peripheral vessels, including calcified below-the-knee (BTK) lesions. Subjects were required to have target lesions in the iliac, femoral, ilio-femoral, popliteal, or infra-popliteal arteries with at least moderate calcification as determined by the investigator, defined as calcification within the lesion on both sides of the vessel assessed by angiography. Adjunctive therapies such as atherectomy, specialty balloons, and stents were allowed. Subjects were followed through discharge.

Key facts

Study ID

NCT05881421

Run by

Shockwave Medical, Inc.

People needed

1373

Starts

2017-11-16

Expected to finish

2021-06-10

Last updated by the study team

2023-05-31

Who can join

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

You may qualify if…

• Subjects were required to meet ALL of the following inclusion criteria in order to be included in this clinical study:
• Subjects intended to be treated with Shockwave Medical Lithoplasty 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 of subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved 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 that met ANY of the following exclusion criteria were not included in this clinical study:
• Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Shockwave Lithoplasty as per Instructions for Use (IFU) or investigator's opinion.
• Subject 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
• 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
• Midwest Cardiovascular Research Foundation — Davenport, Iowa, United States
• Steward St. Elizabeth's Medical Center — Brighton, Massachusetts, United States
• St. Joseph Mercy Oakland — Pontiac, Michigan, United States
• North Mississippi Medical Center — Tupelo, Mississippi, United States
• St. Luke's Cardiovascular Consultants — Kansas City, Missouri, United States
• Mount Sinai West — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• NC Heart & Vascular Research, LLC — Raleigh, North Carolina, United States
• Ohio Health Research Institute — Columbus, Ohio, United States
• St. John Clinic — Bartlesville, Oklahoma, United States
• Providence Heart & Vascular Institute — Portland, Oregon, United States
• Bryn Mawr Hospital — Bryn Mawr, Pennsylvania, United States
• Pinnacle Health Cardiovascular Institute — Harrisburg, Pennsylvania, United States
• The Miriam Hospital — Providence, Rhode Island, United States
• Baptist Medical Center — Memphis, Tennessee, United States
• St. David's Heart and Vascular (Austin Heart) — Austin, Texas, United States
• Baylor Clinic McNair Campus — Houston, Texas, United States

Full record on ClinicalTrials.gov

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