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

Trial details

Who runs it

Johannes Gutenberg University Mainz

Trial code

NCT04606459

Record updated

2023. szeptember 28.

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: 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:; index of microvascular resistances (IMR) >25 and/or; 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: Recent (within 6 months) revascularization by percutaneous coronary intervention (PCI, stent) or coronary artery by-pass surgery (CABG); Known severe reaction to required procedural medications; Contraindication to dual antiplatelet therapy; Recent (within 3 months) acute coronary syndrome; Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the last 3 months; 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; Known allergy to stainless steel or nickel; Left ventricular ejection fraction of <30%; Chronic renal failure (serum creatinine >2mg/dL), and/or on chronic hemodialysis; Subjects presenting at least one of the following criteria will not be enrolled in the trial; Recent (within 30 days) unsuccessful PCI; 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; A pacemaker electrode in the coronary sinus; Tricuspid valve replacement or repair; Moribund, or with comorbidities limiting life expectancy to less than one year; Need for Magnetic Resonance Imaging (MRI) within 8 weeks after reducer implantation; Female of childbearing potential (last menstruation within the last 12 months or who did not undergo tubal ligation, ovariectomy or hysterectomy).

ClinicalTrials.gov NCT04606459