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Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II
NCT05102019 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05102019
The ClinicalTrials.gov registry entry for NCT05102019 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 380 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shockwave Medical, which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05102019 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Florida, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05102019?
This trial is sponsored by Shockwave Medical, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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