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NCT05007925 · ClinicalTrials.gov registry record · NA
Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System
A NA study of Peripheral Artery Disease, sponsored by Shockwave Medical.
- Active
- Registry status
- NA
- Development phase
- 250
- Enrollment target
- 20
- Study locations
NCT05007925: Active NA study of Peripheral Artery Disease, sponsored by Shockwave Medical.
NCT05007925 is a NA study of Peripheral Artery Disease that is active but no longer recruiting, run by Shockwave Medical. The registered enrollment target is 250 participants, above the 122-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (105% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05007925, a NA study of Peripheral Artery Disease, is active but no longer recruiting, sponsored by Shockwave Medical.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 250 participants
- Enrollment target
- 20
- Study locations
Study Summary
To assess the continued safety, effectiveness, and optimal clinical use of the Shockwave Medical Peripheral IVL System for the treatment of calcified, stenotic BTK arteries. Post-market, prospective , multi-center, single-arm study.
Primary Outcome
Procedure Success defined as ≤50% residual stenosis for all treated target lesions without serious angiographic complications (flow-limiting dissection, perforation, distal embolization, or acute vessel closure) as assessed by the angiographic core lab at the final timepoint.
Conditions Studied
Interventions
- DEVICE Intravascular Lithotripsy
Study Locations (20)
California
- UCSF Fresno - Fresno
- Scripps Memorial Hospital - La Jolla
- Cedars-Sinai Medical Center - Los Angeles
- Stanford Hospital - Palo Alto
- UC Davis Health - Sacramento
- St. Helena Hospital - St. Helena
Massachusetts
- Massachusetts General Hospital - Boston
- Southcoast Hospitals Group - New Bedford
Michigan
- McLaren Bay Heart and Vascular - Bay City
- McLaren Greater Lansing - Lansing
Missouri
- St. Luke's Hospital - Kansas City
- Barnes-Jewish Hospital - St Louis
District of Columbia
- MedStar Washington Hospital Center - Washington D.C.
Florida
- Tallahassee Memorial Hospital - Tallahassee
Georgia
- Piedmont Heart Institute - Atlanta
Illinois
- Rush University Medical Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2021-11-18 |
| Est. Completion | 2026-04-01 |
| Phase | NA |
What the registry record for NCT05007925 still lists
NCT05007925 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, above the 122-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (105% higher).
The record links to 1 condition, with Peripheral Artery Disease appearing as the primary indexed condition, and to 1 intervention - of which Intravascular Lithotripsy is the first listed.
NCT05007925 names 20 study sites across 12 states, led by California, Massachusetts, Michigan.
Frequently Asked Questions
What is clinical trial NCT05007925 about?
NCT05007925 is a clinical study titled "Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System". To assess the continued safety, effectiveness, and optimal clinical use of the Shockwave Medical Peripheral IVL System for the treatment of calcified, stenotic BTK arteries. Post-market, prospective , multi-center, single-arm study.
What is the current status of trial NCT05007925?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 250 participants. The study started on 2021-11-18. Estimated completion is 2026-04-01.
What conditions does trial NCT05007925 study?
This clinical trial studies the following conditions: Peripheral Artery Disease.
What interventions are being tested in trial NCT05007925?
The interventions under investigation include: Intravascular Lithotripsy (DEVICE).
Who is sponsoring clinical trial NCT05007925?
This trial is sponsored by Shockwave Medical, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05007925 being conducted?
This trial has 20 study locations across California, District of Columbia, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05007925's enrollment target sits among peer trials
250 7th of 50 higher than 43 of 50 other Peripheral Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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