NCT04606459 COSIMA: COronary SInus Reducer for the Treatment of Refractory Microvascular Angina
| NCT ID | NCT04606459 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johannes Gutenberg University Mainz |
| Condition | Coronary Microvascular Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2021-04-01 |
| Primary Completion | 2025-10-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 144 participants in total. It began in 2021-04-01 with a primary completion date of 2025-10-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Patients with refractory microvascular angina fulfilling the predefined inclusion and exclusion criteria will be enrolled in this randomized trial. The primary objective is to investigate whether the proportion of patients reporting an improvement in Canadian Cardiovascular Society (CCS) angina class (≥2 classes) is different at six months after implantation of a Coronary Sinus Reducer followed by optimal medical therapy (OMT) compared to OMT alone.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 and ≤85 years * Chronic coronary syndrome (including patients with anginal equivalents) refractory angina CCS class III-IV despite guideline-directed medical therapy * Evidence of reversible ischemia on non-invasive testing * Evidence of microvascular disease as diagnosed invasively by at least one of the following: 1. index of microvascular resistances (IMR) \>25 and/or 2. coronary flow reserve (CFR) \<2.0) with fractional flow reserve (FFR)\>0.8. * Willingness to participate and ability to understand, read and sign the informed consent document before enrollment in the trial. Exclusion Criteria: Subjects presenting at least one of the following criteria will not be enrolled in the trial * Recent (within 3 months) acute coronary syndrome * Recent (within 6 months) revascularization by percutaneous coronary intervention (PCI, stent) or coronary artery by-pass surgery (CABG) * Recent (within 30 days) unsuccessful PCI * Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the last 3 months * Left ventricular ejection fraction of \<30% * Mean right atrial pressure \>15mmHg * Anomalous or abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left superior vena cava \[SVC\]) as demonstrated by angiogram * CS diameter at the site of planned Reducer implantation greater than 13mm or less than 9.5mm as measured by angiogram * Severe chronic obstructive pulmonary disease (COPD) indicated by a forced expiratory volume in one second that is less than 55 percent of the predicted value * Severe valvular heart disease * A pacemaker electrode in the coronary sinus * Tricuspid valve replacement or repair * Chronic renal failure (serum creatinine \>2mg/dL), and/or on chronic hemodialysis * Moribund, or with comorbidities limiting life expectancy to less than one year * Known severe reaction to required procedural medications * Known allergy to stainless steel or nickel * Need for Magnetic Resonance Imaging (MRI) within 8 weeks after reducer implantation * Contraindication to dual antiplatelet therapy * Female of childbearing potential (last menstruation within the last 12 months or who did not undergo tubal ligation, ovariectomy or hysterectomy)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04606459 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Coronary Microvascular Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04606459 currently recruiting?
Yes, NCT04606459 is actively recruiting participants. Contact the research team at tommaso.gori@unimedizin-mainz.de for enrollment information.
Where is the NCT04606459 trial being conducted?
This trial is being conducted at Mainz, Germany.
Who is sponsoring the NCT04606459 clinical trial?
NCT04606459 is sponsored by Johannes Gutenberg University Mainz. The trial plans to enroll 144 participants.