DISRUPT PAD III Observational Study

NCT05881421 | Completed

• 1 other identifier: CP 60892 OS
• Study Type: observational
• Target: 1,373
• Locations: 3 countries
• Sites: 30

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.

Conditions

Peripheral Arterial Disease

Keywords

Intravascular Lithotripsy

Outcome Measures

Primary Outcomes (1)

• Procedural Success - Primary Effectiveness Endpoint

  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.

  Peri-procedural, approximately 2 hours

Secondary Outcomes (1)

• Procedural Success - Secondary Effectiveness Endpoint

  Peri-procedural, approximately 2 hours

Eligibility Criteria

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

Study Population

All patients presenting to the study sites with known PAD requiring an interventional procedure were evaluated for eligibility and participation in the study. If a patient met the baseline pre-procedure screening of inclusion and none of the exclusion criteria for the protocol version current at time of screening, and was willing to participate in the study, written consent was obtained. No study-specific requirements were performed prior to obtaining informed consent.

You may qualify if:

• 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 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.

Sponsors & Collaborators

• Shockwave Medical, Inc.: lead

Study Sites (30)

Stanford Hospital

Palo Alto, California, 94304, United States

Location

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, 80045, United States

Location

UCHealth Northern Colorado

Loveland, Colorado, 80538, United States

Location

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Tallahassee Research Institute Inc.

Tallahassee, Florida, 32308, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Alexian Brothers Medical Center

Elk Grove Village, Illinois, 60007, United States

Location

Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52803, United States

Location

Steward St. Elizabeth's Medical Center

Brighton, Massachusetts, 02135, United States

Location

St. Joseph Mercy Oakland

Pontiac, Michigan, 48341, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

St. Luke's Cardiovascular Consultants

Kansas City, Missouri, 64111, United States

Location

Mount Sinai West

New York, New York, 10019, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

NC Heart & Vascular Research, LLC

Raleigh, North Carolina, 27607, United States

Location

Ohio Health Research Institute

Columbus, Ohio, 43214, United States

Location

St. John Clinic

Bartlesville, Oklahoma, 74006, United States

Location

Providence Heart & Vascular Institute

Portland, Oregon, 97225, United States

Location

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States

Location

Pinnacle Health Cardiovascular Institute

Harrisburg, Pennsylvania, 17101, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Baptist Medical Center

Memphis, Tennessee, 38120, United States

Location

St. David's Heart and Vascular (Austin Heart)

Austin, Texas, 78756, United States

Location

Baylor Clinic McNair Campus

Houston, Texas, 77030, United States

Location

Charleston Area Medical Center

Charleston, West Virginia, 25304, United States

Location

Evangelisches Krankenhaus Mulheim an der Ruhr

Mülheim, Germany

Location

St. Franziskus Hospital

Münster, Germany

Location

RoMed Klinikum Rosenheim

Rosenheim, Germany

Location

Auckland City Hospital

Auckland, New Zealand

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: May 31, 2023
• Study Start: November 16, 2017
• Primary Completion: June 10, 2021
• Study Completion: June 10, 2021
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

US (26); DE (3); NZ (1)