DISRUPT PAD III Observational Study (PAD III OS)

Prospective Multi-Center, Post-Market, Observational Study (OS) of the Shockwave Medical, Inc. Intravascular Lithotripsy System in Peripheral Arteries

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease

• Study Type: Observational
• Enrollment (Actual): 1373

Contacts and Locations

Study Locations

• Germany
  • Mülheim, Germany
    • Evangelisches Krankenhaus Mulheim an der Ruhr
  • Münster, Germany
    • St. Franziskus Hospital
  • Rosenheim, Germany
    • RoMed Klinikum Rosenheim
• New Zealand
  • Auckland, New Zealand
    • Auckland City Hospital
• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford hospital
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Rocky Mountain Regional VA Medical Center
    • Loveland, Colorado, United States, 80538
      • UCHealth Northern Colorado
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Florida
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Research Institute Inc.
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Institute
    • Gainesville, Georgia, United States, 30501
      • Northeast Georgia Medical Center
  • Illinois
    • Elk Grove Village, Illinois, United States, 60007
      • Alexian Brothers Medical Center
  • Iowa
    • Davenport, Iowa, United States, 52803
      • Midwest Cardiovascular Research Foundation
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • Steward St. Elizabeth's Medical Center
  • Michigan
    • Pontiac, Michigan, United States, 48341
      • St. Joseph Mercy Oakland
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Cardiovascular Consultants
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10019
      • Mount Sinai West
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • NC Heart & Vascular Research, LLC
  • Ohio
    • Columbus, Ohio, United States, 43214
      • Ohio Health Research Institute
  • Oklahoma
    • Bartlesville, Oklahoma, United States, 74006
      • St. John Clinic
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence Heart & Vascular Institute
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Bryn Mawr Hospital
    • Harrisburg, Pennsylvania, United States, 17101
      • Pinnacle Health Cardiovascular Institute
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Baptist Medical Center
  • Texas
    • Austin, Texas, United States, 78756
      • St. David's Heart and Vascular (Austin Heart)
    • Houston, Texas, United States, 77030
      • Baylor Clinic McNair Campus
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • Charleston Area Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

Subjects were required to meet ALL of the following inclusion criteria in order to be included in this clinical study:

1. 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.
2. Subjects presenting with claudication or CLI by Rutherford Clinical Category 2, 3, 4, 5, or 6 of the target limb.
3. Age of subject is > 18.
4. 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.
5. 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.

Exclusion Criteria:

Subjects that met ANY of the following exclusion criteria were not included in this clinical study:

1. 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.
2. Subject already enrolled in other investigational (interventional) studies that would interfere with study endpoints.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Success - Secondary Effectiveness Endpoint	As secondary analyses, Procedural Success was also assessed on a per-lesion basis, as well as using a <50% residual stenosis threshold.	Peri-procedural, approximately 2 hours

Collaborators and Investigators

• Sponsor: Shockwave Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2017
• Primary Completion (Actual): June 10, 2021
• Study Completion (Actual): June 10, 2021

Study Registration Dates

• First Submitted: May 19, 2023
• First Submitted That Met QC Criteria: May 19, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Intravascular Lithotripsy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: CP 60892 OS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No