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

Launched by JOHANNES GUTENBERG UNIVERSITY MAINZ · Oct 22, 2020

Keywords

ClinConnect Summary

The COSIMA trial is studying a new treatment option for patients suffering from refractory microvascular angina, which is chest pain that doesn't improve with standard medications. The main goal is to see if a device called a Coronary Sinus Reducer, when combined with optimal medical therapy, can help patients feel significantly better compared to just using medication alone. Participants will be observed for six months to track any improvements in their angina symptoms.

To be eligible for this study, participants need to be between 18 and 85 years old and have a specific type of chest pain (classified as CCS class III-IV) that has not responded to standard treatments. They must also show signs of reversible heart issues from certain tests. However, individuals with recent heart conditions, severe heart failure, or other serious health problems may not qualify for the trial. If someone is accepted, they can expect regular follow-ups to monitor their health and any changes in their symptoms after receiving the device. This trial is an important step in finding better treatments for those struggling with this challenging condition.

Gender

ALL

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)