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Tests treatment safety and results for Refractory Angina
Official title Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II
ClinicalTrials.gov ID: NCT05102019
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject is older than 18 years of age
- Symptomatic coronary artery disease (CAD) with greater than or equal to 90 days of persistent refractory angina pectoris classified as CCS Grade III...
- Must have attempted treatment with the maximally tolerated dose of at least three of the four (preferably all four) approved classes of anti-anginal...
- Subject has either no treatment options for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention, or is...
- Evidence of either exercise or pharmacologically induced reversible ischemia severity by stress echo, nuclear study, PET, perfusion MRI, CT...
You likely can't join if
- Recent (within 30 days prior to enrollment) troponin or CKMB positive acute coronary syndrome (NSTEMI or STEMI) Note: people with an elevated...
- Recent successful revascularization by either CABG or PCI within six months prior to enrollment Note: Successful revascularization is defined as any...
- Recent unsuccessful PCI (e.g., failed attempt to open a chronic total occlusion) within 30 days prior to enrollment Note: people with unsuccessful...
- The predominant manifestation of angina is dyspnea Note: some dyspnea may be present with exertion, but the predominant symptom that limits activity...
- Has extra-coronary contributory causes of angina - e.g., untreated hyperthyroidism, untreated anemia (hgb \ 160 mmHg or diastolic blood pressure...
- NYHA Class III or IV heart failure (HF), decompensated HF or hospitalization due to HF during the 90 days prior to enrollment
See the full eligibility criteria
Who can join
- Subject is older than 18 years of age
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 people with multiple...
- Subject is willing and able to sign informed consent
- Subject is willing to comply with the specified follow-up evaluations Angiographic 1) Three-vessel coronary angiography performed within 12 months prior to enrollment demonstrating obstructive CAD (visually estimated...
What rules you out
- Recent (within 30 days prior to enrollment) troponin or CKMB positive acute coronary syndrome (NSTEMI or STEMI) Note: people with an elevated troponin or CKMB without acute coronary syndrome may still be enrolled
- 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...
- Recent unsuccessful PCI (e.g., failed attempt to open a chronic total occlusion) within 30 days prior to enrollment Note: people with unsuccessful PCI that occurred less than 30 days prior to enrollment may still be...
- 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...
- Has extra-coronary contributory causes of angina - e.g., untreated hyperthyroidism, untreated anemia (hgb \ 160 mmHg or diastolic blood pressure \>100 mmHg despite medications), atrial fibrillation with rapid...
- NYHA Class III or IV heart failure (HF), decompensated HF or hospitalization due to HF during the 90 days prior to enrollment
- Life threatening rhythm disorders or any rhythm disorders that would require future placement of an internal defibrillator and/or pacemaker
- 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
- Severe valvular heart disease (any valve)
- Moderate or severe RV dysfunction by echocardiography
- Pacemaker electrode/lead is present in the coronary sinus
- A Class I indication is present for an implantable defibrillator or cardiac resynchronization therapy according to ACCF/AHA/HRS guidelines
- Recent implantation of a new pacemaker or defibrillator lead with electrode in the right atrium within 90 days of enrollment
- Chronic severe renal failure (estimated eGFR less than 30 mL/min/1.73m2 by the MDRD formula) or people on chronic dialysis
- Known allergy to stainless steel or nickel
- 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)...
- 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
- 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)
- 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...
- 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
- Comorbidities limiting life expectancy to less than one year
- Subject is currently hospitalized for definite or suspected COVID-19
- 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
- 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...
- Mean right atrial pressure greater than 15 mmHg assessed during the final screening procedure for eligibility assessment and potential randomization
- Anomalous or abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left superior vena cava [SVC]) as demonstrated by angiogram
- 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-assigned by chance...
- Reversible ischemia: people 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...
- 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...
- In addition to the above inclusion criteria, people must meet all inclusion criteria (except clinical inclusion #5 and angiographic inclusion #1) and none of the exclusion criteria of the main assigned by chance trial...
- Abnormal Coronary Flow Reserve (CFR): people 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...
- Non-obstructive CAD: people 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...
- In addition to the above inclusion criteria, people must meet all inclusion criteria (except clinical inclusion #5 and angiographic inclusion #1) and none of the exclusion criteria of the main assigned by chance trial...
- people 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...
- In addition to the above inclusion criteria, people must meet all inclusion criteria (except clinical inclusion #6) and none of the exclusion criteria of the main assigned by chance trial Prior to inclusion in...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Tucson, Arizona, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Thousand Oaks, California, United States
- Littleton, Colorado, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
- Miami Beach, Florida, United States
- Naples, Florida, United States
- Pensacola, Florida, United States
- Tallahassee, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Gainsville, Georgia, United States
+ 58 more site(s).
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Tucson, Arizona, United States; Long Beach, California, United States; Los Angeles, California, United States; San Diego, California, United States and 72 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.