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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05881421
Registration number
NCT05881421
Ethics application status
Date submitted
19/05/2023
Date registered
31/05/2023
Date last updated
31/05/2023
Titles & IDs
Public title
DISRUPT PAD III Observational Study
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Scientific title
Prospective Multi-Center, Post-Market, Observational Study (OS) of the Shockwave Medical, Inc. Intravascular Lithotripsy System in Peripheral Arteries
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Secondary ID [1]
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CP 60892 OS
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Universal Trial Number (UTN)
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Trial acronym
PAD III OS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Procedural Success - Primary Effectiveness Endpoint
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Assessment method [1]
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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.
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Timepoint [1]
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Peri-procedural, approximately 2 hours
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Secondary outcome [1]
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Procedural Success - Secondary Effectiveness Endpoint
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Assessment method [1]
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As secondary analyses, Procedural Success was also assessed on a per-lesion basis, as well as using a \<50% residual stenosis threshold.
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Timepoint [1]
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Peri-procedural, approximately 2 hours
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Eligibility
Key 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.
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/11/2017
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Date of last participant enrolment
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Actual
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Date of last data collection
Anticipated
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Actual
10/06/2021
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Sample size
Target
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Accrual to date
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Final
1373
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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California
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Colorado
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West Virginia
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Germany
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Mülheim
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Germany
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Münster
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Germany
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Rosenheim
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New Zealand
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Shockwave Medical, Inc.
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05881421
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Public notes
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Contacts
Principal investigator
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05881421
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