DISRUPT PAD III Observational Study
- Conditions
- Peripheral Arterial Disease
- Registration Number
- NCT05881421
- Lead Sponsor
- Shockwave Medical, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1373
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.
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Procedural Success - Primary Effectiveness Endpoint Peri-procedural, approximately 2 hours Defined as final residual stenosis ≤30% without flow-limiting dissection (≥ grade D) by angiographic core lab. In the primary analysis, Procedural Success was assessed on a per-subject basis; for subjects with multiple IVL-treated lesions, Procedural Success was achieved if all lesions met criteria.
- Secondary Outcome Measures
Name Time Method Procedural Success - Secondary Effectiveness Endpoint Peri-procedural, approximately 2 hours As secondary analyses, Procedural Success was also assessed on a per-lesion basis, as well as using a \<50% residual stenosis threshold.
Trial Locations
- Locations (30)
North Mississippi Medical Center
🇺🇸Tupelo, Mississippi, United States
St. Franziskus Hospital
🇩🇪Münster, Germany
Tallahassee Research Institute Inc.
🇺🇸Tallahassee, Florida, United States
Steward St. Elizabeth's Medical Center
🇺🇸Brighton, Massachusetts, United States
NC Heart & Vascular Research, LLC
🇺🇸Raleigh, North Carolina, United States
Stanford Hospital
🇺🇸Palo Alto, California, United States
Mount Sinai West
🇺🇸New York, New York, United States
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
St. John Clinic
🇺🇸Bartlesville, Oklahoma, United States
St. David's Heart and Vascular (Austin Heart)
🇺🇸Austin, Texas, United States
Baptist Medical Center
🇺🇸Memphis, Tennessee, United States
Evangelisches Krankenhaus Mulheim an der Ruhr
🇩🇪Mülheim, Germany
Auckland City Hospital
🇳🇿Auckland, New Zealand
Providence Heart & Vascular Institute
🇺🇸Portland, Oregon, United States
Baylor Clinic McNair Campus
🇺🇸Houston, Texas, United States
RoMed Klinikum Rosenheim
🇩🇪Rosenheim, Germany
Rocky Mountain Regional VA Medical Center
🇺🇸Aurora, Colorado, United States
UCHealth Northern Colorado
🇺🇸Loveland, Colorado, United States
Midwest Cardiovascular Research Foundation
🇺🇸Davenport, Iowa, United States
St. Joseph Mercy Oakland
🇺🇸Pontiac, Michigan, 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
Charleston Area Medical Center
🇺🇸Charleston, West Virginia, United States
Medstar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
St. Luke's Cardiovascular Consultants
🇺🇸Kansas City, Missouri, United States
Alexian Brothers Medical Center
🇺🇸Elk Grove Village, Illinois, United States
Ohio Health Research Institute
🇺🇸Columbus, Ohio, United States