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NCT02923193 · ClinicalTrials.gov registry record · NA
Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III)
A NA study, sponsored by Shockwave Medical.
- Completed
- Registry status
- NA
- Development phase
- 306
- Enrollment target
NCT02923193 is a NA study that has completed, run by Shockwave Medical. The registered enrollment target is 306 participants.
The verdict
NCT02923193, a NA study, has completed, sponsored by Shockwave Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 306 participants
- Enrollment target
Study Summary
Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind, randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard balloon angioplasty used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries. Assuming that roughly 15% of the subjects will be lost-to-follow-up, a total of up to 400 subjects (200 per treatment arm) will be enrolled in the study at up to 60 sites in Europe, the United States and New Zealand. In addition to the randomized study, an observational study of subjects who do not meet the inclusion/exclusion criteria for the randomized study will be conducted. The objective of the observational study is to assess the real-world acute performance of the Shockwave Medical Peripheral Lithoplasty System in the treatment of calcified, stenotic, peripheral arteries. The observational study is a prospective, multi-center, single arm observational study for subjects who do not meet the inclusion/exclusion criteria of the randomized study. A maximum of 1500 subjects at the same 60 sites will be enrolled in the observational study. Once enrollment in the randomized portion of the study is complete, subjects may continue to be enrolled in the observational study provided they meet OS eligibility criteria. Results for the observational study will be reported in a separate record under NCT05881421.
Interventions
- DEVICE Shockwave Lithoplasty® Peripheral Lithoplasty System
- DRUG Medtronic IN.PACT (DCB)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 306 participants |
| Start Date | 2017-02-22 |
| Est. Completion | 2022-06-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02923193
The ClinicalTrials.gov registry entry for NCT02923193 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 306 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 2 interventions - of which Shockwave Lithoplasty® Peripheral Lithoplasty System is the first listed.
NCT02923193 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02923193 about?
NCT02923193 is a clinical study titled "Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III)". Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind, randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard balloon angioplasty used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries. Assumi...
What is the current status of trial NCT02923193?
This trial is currently completed. It is a NA study. The enrollment target is 306 participants. The study started on 2017-02-22. Estimated completion is 2022-06-02.
What interventions are being tested in trial NCT02923193?
The interventions under investigation include: Shockwave Lithoplasty® Peripheral Lithoplasty System (DEVICE), Medtronic IN.PACT (DCB) (DRUG).
Who is sponsoring clinical trial NCT02923193?
This trial is sponsored by Shockwave Medical, which has 13 total clinical trials registered on ClinicalTrials.gov.
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