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PAD III OS: DISRUPT PAD III Observational Study

Sponsor
Shockwave Medical, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05881421
Collaborator
(none)
1,373
Enrollment
30
Locations
42.8
Actual Duration (Months)
45.8
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    1373 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Multi-Center, Post-Market, Observational Study (OS) of the Shockwave Medical, Inc. Intravascular Lithotripsy System in Peripheral Arteries
    Actual Study Start Date :
    Nov 16, 2017
    Actual Primary Completion Date :
    Jun 10, 2021
    Actual Study Completion Date :
    Jun 10, 2021

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford Hospital Palo Alto California United States 94304
    2 Rocky Mountain Regional VA Medical Center Aurora Colorado United States 80045
    3 UCHealth Northern Colorado Loveland Colorado United States 80538
    4 Medstar Washington Hospital Center Washington District of Columbia United States 20010
    5 Tallahassee Research Institute Inc. Tallahassee Florida United States 32308
    6 Piedmont Heart Institute Atlanta Georgia United States 30309
    7 Northeast Georgia Medical Center Gainesville Georgia United States 30501
    8 Alexian Brothers Medical Center Elk Grove Village Illinois United States 60007
    9 Midwest Cardiovascular Research Foundation Davenport Iowa United States 52803
    10 Steward St. Elizabeth's Medical Center Brighton Massachusetts United States 02135
    11 St. Joseph Mercy Oakland Pontiac Michigan United States 48341
    12 North Mississippi Medical Center Tupelo Mississippi United States 38801
    13 St. Luke's Cardiovascular Consultants Kansas City Missouri United States 64111
    14 Mount Sinai West New York New York United States 10019
    15 Columbia University Medical Center New York New York United States 10032
    16 NC Heart & Vascular Research, LLC Raleigh North Carolina United States 27607
    17 Ohio Health Research Institute Columbus Ohio United States 43214
    18 St. John Clinic Bartlesville Oklahoma United States 74006
    19 Providence Heart & Vascular Institute Portland Oregon United States 97225
    20 Bryn Mawr Hospital Bryn Mawr Pennsylvania United States 19010
    21 Pinnacle Health Cardiovascular Institute Harrisburg Pennsylvania United States 17101
    22 The Miriam Hospital Providence Rhode Island United States 02906
    23 Baptist Medical Center Memphis Tennessee United States 38120
    24 St. David's Heart and Vascular (Austin Heart) Austin Texas United States 78756
    25 Baylor Clinic McNair Campus Houston Texas United States 77030
    26 Charleston Area Medical Center Charleston West Virginia United States 25304
    27 Evangelisches Krankenhaus Mulheim an der Ruhr Mülheim Germany
    28 St. Franziskus Hospital Münster Germany
    29 RoMed Klinikum Rosenheim Rosenheim Germany
    30 Auckland City Hospital Auckland New Zealand

    Sponsors and Collaborators

    • Shockwave Medical, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shockwave Medical, Inc.
    ClinicalTrials.gov Identifier:
    NCT05881421
    Other Study ID Numbers:
    • CP 60892 OS
    First Posted:
    May 31, 2023
    Last Update Posted:
    May 31, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Shockwave Medical, Inc.
    Intravascular Lithotripsy
    Additional relevant MeSH terms:
    Peripheral Arterial Disease
    Peripheral Vascular Diseases

    Study Results

    No Results Posted as of May 31, 2023