Clinical trialNCT05102019RecruitingInterventional

Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II

SponsorShockwave Medical, Inc.Enrollment380Refractory Angina

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Gregg W Stone, MD
Mt. Sinai Heart Health
Principal Investigator
clinicaltrials.gov ↗
Timothy D Henry, MD
The Christ Hospital Health Network
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

96 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

Vancouver General Hospital
Vancouver, British Columbia, Canada
David Wood
Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Mariano Labinaz
Recruiting
Toronto General Hospital (uhn)
Toronto, Ontario, Canada
Vladimir Dzavik
Recruiting
Chum
Montreal, Quebec, Canada
Marc Jolicoeur, MD
Recruiting
Iucpq-Ulaval
Québec, Quebec, Canada
Jean-Michael Paradis, MD
Recruiting

United Kingdom

Essex Cardiothoracic Centre
Basildon, United Kingdom
Thomas Keeble, MD
Recruiting
Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom
Alex Zaphiriou, MD
Recruiting
Bristol Heart Institute
Bristol, United Kingdom
Ioannis Felekos, MD
Recruiting
Royal Papworth Hospital
Cambridge, United Kingdom
Stephen Hoole, MD
Recruiting
Dorset County Hospital Nhs Foundation Trust
Dorchester, United Kingdom
Fraser Witherow, MD
Recruiting
Kettering General Hospital
Kettering, United Kingdom
Prashanth Raju, MD
Recruiting
Glenfield Hospital, Leicester
Leicester, United Kingdom
Bhavik Modi, MD
Recruiting
Liverpool Heart and Chest Hospital Nhs Foundation Trust
Liverpool, United Kingdom
Joel Giblett, MD
Recruiting
Barts Health Centre
London, United Kingdom
Anthony Mathur, MD
Recruiting
Imperial College Healthcare Nhs Trust
London, United Kingdom
Rasha Al-Lamee, MD
Recruiting
King'S College Hospital
London, United Kingdom
Jonathan Byrne, MD
Recruiting
Royal Brompton Hospital
London, United Kingdom
Ranil De Silva, MD
Recruiting
Royal Free Hospital
London, United Kingdom
Gerry Coghlan, MD
Recruiting
St. Georges University Hospital
London, United Kingdom
James Spratt, MD
Recruiting
St. Thomas Hospital
London, United Kingdom
Tiffany Patterson, MD
Recruiting
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Bilal Bawamia, MD
Recruiting
Nottingham University Hospital
Nottingham, United Kingdom
Andrew Vanezis, MD
Recruiting
Oxford University Hospital
Oxford, United Kingdom
Giovanni De Maria, MD
Recruiting
Royal Bournemouth Hospital
Poole, United Kingdom
Peter O'Kane, MD
Recruiting
Musgrove Park Hospital
Taunton, United Kingdom
Mohammad Sahebjalal, MD
Recruiting

United States

Mayo Clinic
Phoenix, Arizona, United States
David Fortuin, MD
Recruiting
Honorhealth Research Institute
Scottsdale, Arizona, United States
Taral Patel, MD
Recruiting
University of Arizona Sarver Heart Center
Tucson, Arizona, United States
Michel Corban, MD
Recruiting
Long Beach Va Medical Center
Long Beach, California, United States
Withdrawn
Cedars-Sinai
Los Angeles, California, United States
Suhail Dohad, MD
Recruiting
Usc Keck School of Medicine
Los Angeles, California, United States
Jubin Joseph
Recruiting
Ucsd
San Diego, California, United States
Ehtisham Mahmud, MD
Recruiting
Kaiser Permanente San Francisco
San Francisco, California, United States
Gopi Manthripragada
Recruiting
Ucsf
San Francisco, California, United States
Yousif Ahmad
Recruiting
Los Robles Hospital and Medical Center
Thousand Oaks, California, United States
Saibal Kar, MD
Recruiting
South Denver Cardiology Associates
Littleton, Colorado, United States
Lee McDonald
Recruiting
Yale University
New Haven, Connecticut, United States
Samit Shah, MD
Recruiting
Medstar Cardiovascular Research Network
Washington D.C., District of Columbia, United States
Hayder Hashim, MD
Recruiting
the Cardiac and Vascular Institute
Gainesville, Florida, United States
Matheen Khuddus, MD
Recruiting
Uf Health Jacksonville
Jacksonville, Florida, United States
Daniel Soffer
Recruiting

56 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 4 Jan 2022
Primary completion: 31 Jul 2027
Completion: 31 Jan 2032
Last update posted: 12 Aug 2026
Registered enrollment: 380
Registry id: NCT05102019

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.