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

Recruiting now · Not applicable

Conditions studied: Coronary Microvascular Disease, Refractory Angina

In brief

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.

Key facts

Study ID

NCT04606459

Run by

Johannes Gutenberg University Mainz

People needed

144

Starts

2021-04-01

Expected to finish

2029-10-20

Last updated by the study team

2023-09-28

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Center of Cardiology, Cardiology I, university hospital Mainz — Mainz, Rhineland-Palatinate, Germany (enrolling)

Full record on ClinicalTrials.gov

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