Implantable device could offer new hope for patients with untreatable chest pain

NCT ID NCT05102019

Disease control Sponsor: Shockwave Medical, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 4 times

Summary

This trial tests an implantable device called the Shockwave Reducer for people with severe, persistent chest pain (refractory angina) who cannot have standard treatments like stents or bypass surgery. About 380 participants will either receive the device or a sham procedure. The study measures changes in exercise ability and symptom relief over six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Shockwave Reducer (implantable device)
What this could lead to: If it works, this device could offer a new option to reduce chest pain and improve exercise ability for people with refractory angina who have no other treatment choices.
What could go wrong: This is a mid-stage trial, so results are not yet proven. The device requires implantation, which carries risks like heart attack, bleeding, or need for further procedures.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 380 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2022

Expected to finish

Jan 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject is older than 18 years of age 2. Symptomatic coronary artery disease (CAD) with greater than or equal to 90 days of persistent refractory angina pectoris classified as CCS Grade III or IV despite maximally tolerated guideline directed medical therapy as determined by the local heart team and confirmed by a Central Screening Eligibility Committee Note: subjects may also have exertional dyspnea, but the symptoms that limit activity must be anginal in nature (including chest pain, pressure, heaviness, discomfort, with or without radiation to the neck, jaw, shoulders, arms, or other location) and not dyspnea 3. Must have attempted treatment with the maximally tolerated dose of at least three of the four (preferably all four) approved classes of anti-anginal agents: long-acting nitrates, calcium channel blockers (either a dihydropyridine or a non-dihydropyridine), beta blockers, and ranolazine. The regimen must be stable for at least 30 days prior to enrollment, must remain stable from enrollment to randomization, and there must be no intent to change the medical regimen for at least 12 months after randomization Note: If the dose of a medication was increased or decreased for a temporary period and then returned to the original dose, which will then be continued for at least 12 months after randomization, the subject may be immediately enrolled without needing to otherwise requalify 4. Subject has either no treatment options for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention, or is otherwise unsuitable or high risk for revascularization as determined by the local heart team, and confirmed by a Central Screening Eligibility Committee 5. Evidence of either exercise or pharmacologically induced reversible ischemia severity by stress echo, nuclear study, PET, perfusion MRI, CT perfusion, FFR-CT, FFR, iFR, or other non-hyperemic FDA approved tests (such as diastolic hyperaemia free ratio \[DRF\] or resting full-cycle ratio \[RFR\] in the distribution of the left coronary artery (LCA), performed within 12 months prior to enrollment Note: If the subject has evidence of ischemia in both the LCA and RCA distributions, the extent of ischemia must be greater in the LCA distribution Note: The qualifying assessment must be performed after any myocardial infarction, CABG, or successful PCI within the prior 12 months. For subjects with multiple assessments, the one performed closest to enrollment will serve as the qualifying study 6. Functional limitation due to refractory angina as defined by a modified Bruce exercise tolerance test duration of greater than or equal to 2 minutes but less than or equal to 10 minutes, performed while the subject is maintained on their stable regimen of maximally tolerated doses of anti-anginal medications Note: The ETT variability must be less than 20% between last two ETTs performed. 7. Left ventricular ejection fraction (LVEF) greater than or equal to 30% within the 12-months prior to enrollment Note: The LVEF must be reassessed after any intervening myocardial infarction. For subjects with multiple assessments, the most recent LVEF assessment is used as the qualifying test. 8. Subject is willing and able to sign informed consent 9. Subject is willing to comply with the specified follow-up evaluations Angiographic Inclusion Criteria: 1\) Three-vessel coronary angiography performed within 12 months prior to enrollment demonstrating obstructive CAD (visually estimated diameter stenosis of ≥70% or ≥50% - \<70% with fractional flow reserve (FFR) value of ≤0.80 or an iFR or other FDA-approved/cleared non-hyperemic physiological assessment (such as DFR or RFR) of ≤0.89 in one or more lesions) in the left coronary artery (main epicardial vessels or branches) that is not suitable for and will not be treated with PCI or CABG as determined by the local heart team Note: The qualifying 3-vessel angiogram must be performed after any myocardial infarction, PCI, or CABG within the 12 months prior to enrollment. For patients with multiple 3-vessel angiograms, the one performed closest to enrollment will serve as the qualifying study Exclusion Criteria: 1. Recent (within 30 days prior to enrollment) troponin or CKMB positive acute coronary syndrome (NSTEMI or STEMI) Note: subjects with an elevated troponin or CKMB without acute coronary syndrome may still be enrolled 2. Recent successful revascularization by either CABG or PCI within six months prior to enrollment Note: Successful revascularization is defined as any CABG procedure, or any PCI procedure with a reduction of one or more lesions to \<50% diameter stenosis Note: Subjects with successful revascularization by either CABG or PCI that occurred less than six months prior to enrollment may still be approved for participation in the trial if revascularization was completed six months prior to procedure and CSEC approves subject participation 3. Recent unsuccessful PCI (e.g., failed attempt to open a chronic total occlusion) within 30 days prior to enrollment Note: Subjects with unsuccessful PCI that occurred less than 30 days prior to enrollment may still be approved for participation in the trial if PCI was completed 30 days prior to procedure and CSEC approves subject participation 4. The predominant manifestation of angina is dyspnea Note: some dyspnea may be present with exertion, but the predominant symptom that limits activity must be angina (i.e., chest pain, pressure, tightness, heaviness, or discomfort, with or without radiation to the neck, jaw, shoulders, arms, or other location) 5. Has extra-coronary contributory causes of angina - e.g., untreated hyperthyroidism, untreated anemia (hgb \<10 g/dL), uncontrolled hypertension (systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg despite medications), atrial fibrillation with rapid ventricular response (consistently \>100 bpm despite medications) or other tachyarrhythmia, severe aortic stenosis, hypertrophic cardiomyopathy with left ventricular outflow tract obstruction or asymmetric septal hypertrophy (concentric left ventricular hypertrophy is not an exclusion criterion), or epicardial vasospasm disease/coronary artery vasospasm (CAS)/vasospastic angina (VSA) 6. NYHA Class III or IV heart failure (HF), decompensated HF or hospitalization due to HF during the 90 days prior to enrollment 7. Life threatening rhythm disorders or any rhythm disorders that would require future placement of an internal defibrillator and/or pacemaker 8. Severe chronic obstructive pulmonary disease (COPD) as indicated by a forced expiratory volume in one second (FEV1) that is less than 55% of the predicted value, or need for home daytime oxygen or oral steroids 9. Severe valvular heart disease (any valve) 10. Moderate or severe RV dysfunction by echocardiography 11. Pacemaker electrode/lead is present in the coronary sinus 12. A Class I indication is present for an implantable defibrillator or cardiac resynchronization therapy according to ACCF/AHA/HRS guidelines 13. Recent implantation of a new pacemaker or defibrillator lead with electrode in the right atrium within 90 days of enrollment 14. Chronic severe renal failure (estimated eGFR less than 30 mL/min/1.73m2 by the MDRD formula) or subjects on chronic dialysis 15. Known allergy to stainless steel or nickel 16. Any clinical condition that might interfere with the trial protocol or the subject's ability to be compliant with the trial protocol (e.g., active alcohol or drug abuse, dementia, magnetic resonances imaging (MRI) planned within 8 weeks of procedure) 17. Currently enrolled in another investigational device or drug trial that has not reached its primary endpoint or that might clinically interfere with the current trial endpoints or procedures 18. Pregnant or planning pregnancy within the next 12 months (women of reproductive potential must have a negative pregnancy test within 7 days of the procedure) 19. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention. 20. Inability to tolerate dual antiplatelet therapy for 6 months if not on a chronic oral anticoagulant, or inability to tolerate a P2Y12 inhibitor for at least 6 months if on a chronic oral anticoagulant 21. Comorbidities limiting life expectancy to less than one year 22. Subject is currently hospitalized for definite or suspected COVID-19 23. Subject has previously been symptomatic with or hospitalized for COVID-19 and has been asymptomatic for \<8 weeks prior to enrollment or has not returned to his or her prior baseline (pre-COVID-19) clinical condition 24. Subject is asymptomatic but has had a positive PCR or antigen test for COVID-19 within the past 4 weeks prior to enrollment Angiographic/Hemodynamic Exclusion Criteria: 1\) Coronary anatomy amenable to revascularization of ischemic myocardial territory by either PCI or CABG with at least moderate likelihood of long-term alleviation of angina or angina equivalent symptoms, as per the assessment of the local heart team. Note: If a pathway to coronary revascularization is present which, in the opinion of the local heart team, is reasonably low risk and reasonably likely to provide long-term symptom relief and the subject refuses the revascularization procedure, the patient is ineligible for randomization Procedural Angiographic/Hemodynamic Randomization Exclusion Criteria: 1. Mean right atrial pressure greater than 15 mmHg assessed during the final screening procedure for eligibility assessment and potential randomization 2. Anomalous or abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left superior vena cava \[SVC\]) as demonstrated by angiogram 3. The CS diameter at the most proximal end of the planned implant region (2-4 cm distal to the coronary sinus ostium) is less than 9.5 mm or greater than 13.0 mm Single-arm Registry (Unblinded, Non-Randomized Treatment Arm) Inclusion/Exclusion Criteria: Subject can be included in the single-arm registry if they fall into one of the three categories with inclusions and exclusion criteria as described below. Predominant right coronary disease subjects (RCA): 1. Reversible ischemia: Subjects with evidence of either exercise or pharmacologically induced reversible ischemia by stress echo, nuclear study, PET, perfusion MRI, CT perfusion, FFR-CT, FFR, iFR, or other non-hyperemic FDA approved or cleared tests (such as DFR or RFR) in the distribution of the right coronary artery (RCA), performed within 12 months prior to enrollment. Note: If the subject has evidence of ischemia in both the LCA and RCA distributions, the extent of ischemia must be greater in the RCA distribution Note: The qualifying assessment must be performed after any myocardial infarction, CABG, or successful PCI within the prior 12 months. If the anti-anginal medication regimen is permanently changed after the assessment of ischemia, the test must be repeated. For subjects with multiple assessments, the one performed closest to enrollment will serve as the qualifying study 2. Obstructive CAD: Three-vessel coronary angiography performed within the 12 months prior to enrollment demonstrating obstructive CAD (visually assessed diameter stenosis of ≥70% or ≥50% - \<70% with fractional flow reserve (FFR) value of ≤0.80 or an iFR or other FDA-approved/cleared non-hyperemic physiological assessment (such as DFR or RFR) of ≤0.89 in one or more lesions) in the RCA (main epicardial vessels or branches) that is not suitable for and will not be treated with PCI or CABG as determined by the local heart team. Note: The qualifying assessment must be performed after any myocardial infarction, PCI or CABG within the prior 12 months. For subjects with multiple assessments, the one performed closest to enrollment will serve as the qualifying study 3. In addition to the above inclusion criteria, subjects must meet all inclusion criteria (except clinical inclusion #5 and angiographic inclusion #1) and none of the exclusion criteria of the main randomized trial Non-obstructive coronary artery disease subjects (ANOCA) 1. Abnormal Coronary Flow Reserve (CFR): subjects must have either abnormal PET CFR (\< 2.0), abnormal perfusion CMR (cardiac MRI) CFR (\<1.85), or abnormal invasive CFR (\<2.5) in at least one main epicardial coronary artery performed within 12 months prior to enrollment Note: Subjects may or may not have evidence of either exercise or pharmacologically induced reversible ischemia by stress echo, nuclear study, PET, perfusion MRI, or CT perfusion 2. Non-obstructive CAD: subjects have non-obstructive coronary disease (estimated diameter stenosis in all coronary lesions is \<50% and (if performed) FFR ≥0.81 or a non-hyperemic test is ≥0.90) demonstrated on three-vessel coronary angiography performed within the 12 months prior to enrollment. If an estimated diameter stenosis is ≥50% to \<70%, the patient may still qualify if FFR ≥0.81 or a non-hyperemic test is ≥0.90 in that vessel. If both FFR and a non-hyperemic test are performed, both must be negative. Note: The qualifying 3-vessel angiogram must be performed after any myocardial infarction, PCI or CABG within the 12 months prior to enrollment. For patients with multiple 3-vessel angiograms, the one performed closest to enrollment will serve as the qualifying study 3. In addition to the above inclusion criteria, subjects must meet all inclusion criteria (except clinical inclusion #5 and angiographic inclusion #1) and none of the exclusion criteria of the main randomized trial Subjects unable to complete ETT 1. Subjects must be unable to complete the required COSIRA-II 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 (e.g., wheelchair, cane, rollator, crutches, or knee walker). 2. In addition to the above inclusion criteria, subjects must meet all inclusion criteria (except clinical inclusion #6) and none of the exclusion criteria of the main randomized trial Prior to inclusion in single-arm registry, all subjects will be reviewed by the Central Screening Eligibility Committee to ensure that they meet registry inclusion criteria and are not eligible for enrollment into the randomized study.

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Conditions

The condition(s) this trial relates to.

Angina Pectoris coronary artery disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Refractory angina

How to take part

Only the study team decides who joins. These are the ways to reach them.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

91 sites in 3 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Show contact details

Locations

Advocate Aurora Research Institute
RECRUITING

Milwaukee, Wisconsin, 53215, United States
Allegheny General Hospital
RECRUITING

Pittsburgh, Pennsylvania, 15212, United States
Ascension Sacred Heart
RECRUITING

Pensacola, Florida, 32504, United States
Ascension St. John
RECRUITING

Tulsa, Oklahoma, 74104, United States
Ascension St. Vincent Heart Center
RECRUITING

Carmel, Indiana, 46920, United States
Ascension Texas Cardiovascular
RECRUITING

Austin, Texas, 78705, United States
Barts Health Centre
RECRUITING

London, E1 1FR, United Kingdom
Baystate Medical Center
RECRUITING

Springfield, Massachusetts, 01199, United States
Brigham and Women's Hospital
RECRUITING

Boston, Massachusetts, 02120, United States
Bristol Heart Institute
RECRUITING

Bristol, BS2 8HW, United Kingdom
CHUM
RECRUITING

Montreal, Quebec, H2X 0C1, Canada
Cardiology Associates of North Mississippi
WITHDRAWN

Tupelo, Mississippi, 38801, United States
Cardiovascular Institute of the South
RECRUITING

Houma, Louisiana, 70360, United States
Cardiovascular Research Institute of Kansas
WITHDRAWN

Wichita, Kansas, 67226, United States
Cedars-Sinai
RECRUITING

Los Angeles, California, 90048, United States
Cleveland Clinic
RECRUITING

Cleveland, Ohio, 44195, United States
Columbia University Medical Center/NYPH
RECRUITING

New York, New York, 10032, United States
Community Hospital - Munster
RECRUITING

Munster, Indiana, 46321, United States
Corewell Health
RECRUITING

Grand Rapids, Michigan, 59403, United States
Dorset County Hospital NHS Foundation Trust
RECRUITING

Dorchester, DT1 2JY, United Kingdom
Emory Hospital
RECRUITING

Atlanta, Georgia, 30308, United States
Essex Cardiothoracic Centre
RECRUITING

Basildon, SS16 5NL, United Kingdom
Freeman Hospital
RECRUITING

Newcastle upon Tyne, NE7 7DN, United Kingdom
Glenfield Hospital, Leicester
RECRUITING

Leicester, LE3 9QP, United Kingdom
HCA Houston Healthcare Medical Center
WITHDRAWN

Houston, Texas, 77004, United States
Hackensack University
RECRUITING

Hackensack, New Jersey, 07601, United States
Henry Ford Hospital
RECRUITING

Detroit, Michigan, 48202, United States
Henry Ford Providence
RECRUITING

Southfield, Michigan, 48075, United States
Henry Ford St. Johns
RECRUITING

Detroit, Michigan, 48236, United States
HonorHealth Research Institute
RECRUITING

Scottsdale, Arizona, 85258, United States
Houston Methodist
RECRUITING

Houston, Texas, 77030, United States
IUCPQ-Ulaval
RECRUITING

Québec, Quebec, G1V4G5, Canada
Imperial College Healthcare NHS Trust
RECRUITING

London, W12 0HS, United Kingdom
Jackson Heart Clinic
RECRUITING

Jackson, Mississippi, 39216, United States
Kaiser Permanente San Francisco
RECRUITING

San Francisco, California, 94115, United States
Kettering General Hospital
RECRUITING

Kettering, NN16 8UZ, United Kingdom
King's College Hospital
RECRUITING

London, SE5 9RS, United Kingdom
Liverpool Heart and Chest Hospital NHS Foundation Trust
RECRUITING

Liverpool, L14 3PE, United Kingdom
Long Beach VA Medical Center
WITHDRAWN

Long Beach, California, 90822, United States
Los Robles Hospital and Medical Center
RECRUITING

Thousand Oaks, California, 91360, United States
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114, United States
Mayo Clinic
RECRUITING

Rochester, Minnesota, 55905, United States
Mayo Clinic
RECRUITING

Phoenix, Arizona, 85054, United States
MedStar Cardiovascular Research Network
RECRUITING

Washington D.C., District of Columbia, 20010, United States
Medical City Fort Worth
RECRUITING

Fort Worth, Texas, 76104, United States
Methodist Hospital of San Antonio
RECRUITING

San Antonio, Texas, 78229, United States
Minneapolis Heart Institute Foundation
RECRUITING

Minneapolis, Minnesota, 55407, United States
Mount Sinai Medical Center
RECRUITING

New York, New York, 10003, United States
Mount Sinai Miami
RECRUITING

Miami Beach, Florida, 33140, United States
Musgrove Park Hospital
RECRUITING

Taunton, TA1 5DA, United Kingdom

Contact Email: •••••@•••••
NCH Healthcare - Naples
RECRUITING

Naples, Florida, 34102, United States
NYU Langone
RECRUITING

New York, New York, 10010, United States
Northeast Georgia
RECRUITING

Gainsville, Georgia, 30501, United States
Northside Hospital
WITHDRAWN

Atlanta, Georgia, 30342, United States
Northwestern University
RECRUITING

Chicago, Illinois, 60611, United States
Nottingham University Hospital
RECRUITING

Nottingham, NG5, United Kingdom
Novant Health
RECRUITING

Charlotte, North Carolina, 28204, United States
Oxford University Hospital
RECRUITING

Oxford, OX3 9DU, United Kingdom
Providence Heart Institute
RECRUITING

Portland, Oregon, 97225, United States
Queen Elizabeth Hospital Birmingham
RECRUITING

Birmingham, B15 2GW, United Kingdom
Royal Bournemouth Hospital
RECRUITING

Poole, BH15 2JB, United Kingdom
Royal Brompton Hospital
RECRUITING

London, SW3 6NP, United Kingdom
Royal Free Hospital
RECRUITING

London, NW3 2QG, United Kingdom
Royal Papworth Hospital
RECRUITING

Cambridge, |CB2 0AY, United Kingdom
Saint Luke's Hospital
RECRUITING

Kansas City, Missouri, 64111, United States
Sentara Norfolk General Hospital
RECRUITING

Norfolk, Virginia, 23507, United States
South Denver Cardiology Associates
RECRUITING

Littleton, Colorado, 80120, United States
Southern Illinois University
RECRUITING

Springfield, Illinois, 62781, United States
St. Francis Hospital
RECRUITING

Roslyn, New York, 11576, United States
St. Georges University Hospital
RECRUITING

London, SW17 0QT, United Kingdom
St. Thomas Hospital
RECRUITING

London, SE1 7EH, United Kingdom
Tallahassee Research Institute
RECRUITING

Tallahassee, Florida, 32308, United States
Tampa General - USF Cardiology
RECRUITING

Tampa, Florida, 33606, United States
Texas Heart Institute
RECRUITING

Houston, Texas, 77030, United States
The Cardiac and Vascular Institute
RECRUITING

Gainesville, Florida, 32605, United States
The Christ Hospital
RECRUITING

Cincinnati, Ohio, 45219, United States
The Heart Hospital Baylor Plano
RECRUITING

Plano, Texas, 75093, United States
The Ohio State University
RECRUITING

Columbus, Ohio, 43210, United States
Toronto General Hospital (UHN)
RECRUITING

Toronto, Ontario, M5G 2C4, Canada
TriStar Centennial Medical Center
RECRUITING

Nashville, Tennessee, 37203, United States
UCSD
RECRUITING

San Diego, California, 92037, United States
UCSF
RECRUITING

San Francisco, California, 94117, United States
UF Health Jacksonville
RECRUITING

Jacksonville, Florida, 32209, United States
USC Keck School of Medicine
RECRUITING

Los Angeles, California, 90033, United States
University of Arizona Sarver Heart Center
RECRUITING

Tucson, Arizona, 85724, United States
University of Kansas Medical Center
RECRUITING

Kansas City, Kansas, 66160, United States
University of Michigan
RECRUITING

Ann Arbor, Michigan, 48109, United States
University of Ottawa Heart Institute
RECRUITING

Ottawa, Ontario, K1y4W7, Canada
University of Texas Health Science Center at Houston
RECRUITING

Houston, Texas, 77030, United States
University of Virginia
RECRUITING

Charlottesville, Virginia, 22908, United States
University of Wisconsin
RECRUITING

Madison, Wisconsin, 53792, United States
Vancouver General Hospital
RECRUITING

Vancouver, British Columbia, V521M9, Canada
Vanderbilt Heart
RECRUITING

Nashville, Tennessee, 37232, United States
Weill Cornell Medicine
RECRUITING

New York, New York, 10021, United States
Wellstar Kennestone Hospital
RECRUITING

Marietta, Georgia, 30062, United States
Yale University
RECRUITING

New Haven, Connecticut, 06519, United States

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