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NCT05102019 · ClinicalTrials.gov registry record · NA
Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II
A NA study of Refractory Angina, sponsored by Shockwave Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 380
- Enrollment target
- 20
- Study locations
NCT05102019: Recruiting NA study of Refractory Angina, sponsored by Shockwave Medical.
NCT05102019 is a NA study of Refractory Angina that is actively recruiting participants, run by Shockwave Medical. The registered enrollment target is 380 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05102019, a NA study of Refractory Angina, is actively recruiting participants, sponsored by Shockwave Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 380 participants
- Enrollment target
- 20
- Study locations
Study Summary
To demonstrate the safety and effectiveness of the Shockwave Reducer for treatment of patients with refractory angina pectoris treated with maximally tolerated guideline-directed medical therapy who demonstrate objective evidence of reversible myocardial ischemia in the distribution of the left coronary artery and who are deemed unsuitable for revascularization. A non-randomized single-arm registry will further assess the safety and effectiveness of the Shockwave Reducer in selected subjects with reversible myocardial ischemia in the distribution of the right coronary artery and who are deemed unsuitable for revascularization, subjects without documented obstructive coronary disease and abnormal coronary flow reserve (ANOCA), and subjects who cannot complete an exercise tolerance test due to lower limb amputation (above the ankle) or other physiologic condition with documented chronic mobility or balance issues that require the use of a walking aid.
Primary Outcome
Change in total exercise duration in a modified Bruce treadmill exercise tolerance testing evaluation in the Treatment arm compared to Sham-control arm. Change in SAQ clinical summary score assessed at 6 months post procedure compared to baseline in the Treatment arm compared to the Sham-control arm.
Conditions Studied
Interventions
- DEVICE Arm 1: treatment with Shockwave Reducer
- OTHER Arm 2 (control): Implantation procedure with no device implanted
- DEVICE Arm 3 (unblinded, non-randomized): Single arm registry
Study Locations (20)
Florida
- The Cardiac and Vascular Institute - Gainesville
- UF Health Jacksonville - Jacksonville
- Mount Sinai Miami - Miami Beach
- NCH Healthcare - Naples - Naples
- Ascension Sacred Heart - Pensacola
- Tallahassee Research Institute - Tallahassee
- Tampa General - USF Cardiology - Tampa
California
- Long Beach VA Medical Center - Long Beach
- Cedars-Sinai - Los Angeles
- UCSD - San Diego
- Kaiser Permanente San Francisco - San Francisco
- UCSF - San Francisco
- Los Robles Hospital and Medical Center - Thousand Oaks
Arizona
- Mayo Clinic - Phoenix
- HonorHealth Research Institute - Scottsdale
- University of Arizona Sarver Heart Center - Tucson
Colorado
- South Denver Cardiology Associates - Littleton
Connecticut
- Yale University - New Haven
District of Columbia
- MedStar Cardiovascular Research Network - Washington D.C.
Georgia
- Emory Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 380 participants |
| Start Date | 2022-01-04 |
| Est. Completion | 2032-01 |
| Phase | NA |
What NCT05102019 shows while recruiting
NCT05102019 is an interventional study that assigns participants to a tested intervention. The registered 380 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Refractory Angina appearing as the primary indexed condition, and to 3 interventions - of which Arm 1: treatment with Shockwave Reducer is the first listed.
NCT05102019 names 20 study sites across 7 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT05102019 about?
NCT05102019 is a clinical study titled "Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II". To demonstrate the safety and effectiveness of the Shockwave Reducer for treatment of patients with refractory angina pectoris treated with maximally tolerated guideline-directed medical therapy who demonstrate objective evidence of reversible myocardial ischemia in the distribution of the left coro...
What is the current status of trial NCT05102019?
This trial is currently recruiting. It is a NA study. The enrollment target is 380 participants. The study started on 2022-01-04. Estimated completion is 2032-01.
What conditions does trial NCT05102019 study?
This clinical trial studies the following conditions: Refractory Angina.
What interventions are being tested in trial NCT05102019?
The interventions under investigation include: Arm 1: treatment with Shockwave Reducer (DEVICE), Arm 2 (control): Implantation procedure with no device implanted (OTHER), Arm 3 (unblinded, non-randomized): Single arm registry (DEVICE).
Who is sponsoring clinical trial NCT05102019?
This trial is sponsored by Shockwave Medical, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05102019 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05102019's enrollment target sits among peer trials
380 273rd of 2000 higher than 1,727 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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