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NCT05881421 · ClinicalTrials.gov registry record
DISRUPT PAD III Observational Study
A clinical trial, sponsored by Shockwave Medical.
- Completed
- Registry status
- 1,373
- Enrollment target
NCT05881421 is a clinical trial that has completed, run by Shockwave Medical. The registered enrollment target is 1,373 participants.
The verdict
NCT05881421 has completed, sponsored by Shockwave Medical.
- COMPLETED
- Registry status
- 1,373 participants
- Enrollment target
Study 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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,373 participants |
| Start Date | 2017-11-16 |
| Est. Completion | 2021-06-10 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05881421
The ClinicalTrials.gov registry entry for NCT05881421 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 1,373 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shockwave Medical, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT05881421 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05881421 about?
NCT05881421 is a clinical study titled "DISRUPT PAD III Observational Study". 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 Peripher...
What is the current status of trial NCT05881421?
This trial is currently completed. The enrollment target is 1,373 participants. The study started on 2017-11-16. Estimated completion is 2021-06-10.
Who is sponsoring clinical trial NCT05881421?
This trial is sponsored by Shockwave Medical, which has 13 total clinical trials registered on ClinicalTrials.gov.
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