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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: Completed study, sponsored by Shockwave Medical.
NCT05881421 is a clinical trial that has completed, run by Shockwave Medical. The registered enrollment target is 1,373 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,373 participants |
| Start Date | 2017-11-16 |
| Est. Completion | 2021-06-10 |
What the finished NCT05881421 record still lists
NCT05881421 is an observational study that tracks outcomes without assigning an intervention. Its 1,373 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT05881421 does not publish any study locations in the registry export this page uses.
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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