RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-01-04

Study Completion:2032-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05102019

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 and while the patient is maintained on their stable regimen of maximally tolerated doses of anti-anginal medications 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. 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 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	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 3. Recent unsuccessful PCI (e.g., failed attempt to open a chronic total occlusion) within 30 days prior to enrollment 4. The predominant manifestation of angina is dyspnea 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

Inclusion Criteria

Exclusion 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 and while the patient is maintained on their stable regimen of maximally tolerated doses of anti-anginal medications 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. 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
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

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
3. Recent unsuccessful PCI (e.g., failed attempt to open a chronic total occlusion) within 30 days prior to enrollment
4. The predominant manifestation of angina is dyspnea
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

Contacts and Locations

Study Contact

COSIRA-II Study Team

CONTACT

Fax: 1-888-887-8097

connect.cosira2@shockwavemedical.com

Principal Investigator

Timothy D Henry, MD

PRINCIPAL_INVESTIGATOR

The Christ Hospital Health Network

Gregg W Stone, MD

PRINCIPAL_INVESTIGATOR

Mt. Sinai Heart Health

Study Locations (Sites)

Mayo Clinic

Phoenix, Arizona, 85054

United States

HonorHealth Research Institute

Scottsdale, Arizona, 85258

United States

University of Arizona Sarver Heart Center

Tucson, Arizona, 85724

United States

Long Beach VA Medical Center

Long Beach, California, 90822

United States

Cedars-Sinai

Los Angeles, California, 90048

United States

UCSD

San Diego, California, 92037

United States

Kaiser Permanente San Francisco

San Francisco, California, 94115

United States

Los Robles Hospital and Medical Center

Thousand Oaks, California, 91360

United States

South Denver Cardiology Associates

Littleton, Colorado, 80120

United States

Yale University

New Haven, Connecticut, 06519

United States

MedStar Cardiovascular Research Network

Washington, District of Columbia, 20010

United States

The Cardiac and Vascular Institute

Gainesville, Florida, 32605

United States

UF Health Jacksonville

Jacksonville, Florida, 32209

United States

Mount Sinai Miami

Miami Beach, Florida, 33140

United States

NCH Healthcare - Naples

Naples, Florida, 34102

United States

Ascension Sacred Heart

Pensacola, Florida, 32504

United States

Tallahassee Research Institute

Tallahassee, Florida, 32308

United States

Emory Hospital

Atlanta, Georgia, 30308

United States

Northside Hospital

Atlanta, Georgia, 30342

United States

Wellstar Kennestone Hospital

Marietta, Georgia, 30062

United States

Ascension St. Vincent Heart Center

Carmel, Indiana, 46920

United States

Cardiovascular Research Institute of Kansas

Wichita, Kansas, 67226

United States

Cardiovascular Institute of the South

Houma, Louisiana, 70360

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Brigham and Women's Hospital

Boston, Massachusetts, 02120

United States

Baystate Medical Center

Springfield, Massachusetts, 01199

United States

University of Michigan

Ann Arbor, Michigan, 48109

United States

Henry Ford Hospital

Detroit, Michigan, 48202

United States

Henry Ford Providence

Southfield, Michigan, 48075

United States

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

Cardiology Associates of North Mississippi

Tupelo, Mississippi, 38801

United States

Saint Luke's Hospital

Kansas City, Missouri, 64111

United States

Hackensack University

Hackensack, New Jersey, 07601

United States

Mount Sinai Medical Center

New York, New York, 10003

United States

Columbia University Medical Center/NYPH

New York, New York, 10032

United States

St. Francis Hospital

Roslyn, New York, 11576

United States

Novant Health

Charlotte, North Carolina, 28204

United States

The Christ Hospital

Cincinnati, Ohio, 45219

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

The Ohio State University

Columbus, Ohio, 43210

United States

Ascension St. John

Tulsa, Oklahoma, 74104

United States

Providence Heart Institute

Portland, Oregon, 97225

United States

TriStar Centennial Medical Center

Nashville, Tennessee, 37203

United States

Vanderbilt Heart

Nashville, Tennessee, 37232

United States

Medical City Fort Worth

Fort Worth, Texas, 76104

United States

HCA Houston Healthcare Medical Center

Houston, Texas, 77004

United States

Houston Methodist

Houston, Texas, 77030

United States

Texas Heart Institute

Houston, Texas, 77030

United States

University of Texas Health Science Center at Houston

Houston, Texas, 77030

United States

The Heart Hospital Baylor Plano

Plano, Texas, 75093

United States

Methodist Hospital of San Antonio

San Antonio, Texas, 78229

United States

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507

United States

University of Wisconsin

Madison, Wisconsin, 53792

United States

Advocate Aurora Research Institute

Milwaukee, Wisconsin, 53215

United States

Collaborators and Investigators

Sponsor: Shockwave Medical, Inc.

Timothy D Henry, MD, PRINCIPAL_INVESTIGATOR, The Christ Hospital Health Network
Gregg W Stone, MD, PRINCIPAL_INVESTIGATOR, Mt. Sinai Heart Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-04

Study Completion Date2032-01

Study Record Updates

Study Start Date2022-01-04

Study Completion Date2032-01

Terms related to this study

Additional Relevant MeSH Terms

Refractory Angina