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RECRUITING

NCT04606459

COSIMA: COronary SInus Reducer for the Treatment of Refractory Microvascular Angina

Sponsor: Johannes Gutenberg University Mainz

View on ClinicalTrials.gov

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.

Official title: A Multicentric Randomized Open Label Controlled Superiority Trial to Evaluate the Effectiveness of a Therapy With a Coronary Sinus Reducer as Compared to Guideline-directed Medical Therapy in Patients With Refractory Microvascular Angina

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2021-04-01

Completion Date

2029-10-20

Last Updated

2023-09-28

Healthy Volunteers

Conditions

Coronary Microvascular Disease Refractory Angina

Interventions

DEVICE

Coronary sinus reducer

The Reducer System comprises the Reducer device (Reducer) pre-mounted on the Reducer Balloon Catheter. The Reducer System is available in one model size. The Reducer is a sterile, single-use, implantable device designed to establish a narrowing in the coronary sinus (CS) and is intended to improve perfusion to ischemic myocardium in the presence of reversible ischemic heart disease to alleviate the symptoms of refractory angina. The device is implanted percutaneously through the right internal jugular vein into the CS. The Reducer is pre-mounted (crimped) on the Reducer Balloon Catheter which, after inflation, causes device expansion and apposition with the vessel wall. The balloon catheter is then deflated and removed from the CS, leaving the device permanently implanted.

OTHER

Optimal medical therapy

Guideline-directed medical therapy

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)

Locations (1)

Center of Cardiology, Cardiology I, university hospital Mainz

Mainz, Rhineland-Palatinate, Germany