COSIMA: COronary SInus Reducer for the Treatment of Refractory Microvascular Angina
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorJohannes Gutenberg University Mainz
About this trial
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
Qualifiers
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
index of microvascular resistances (IMR) >25 and/or
Disqualifiers
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
Trial design
Treatments tested in this trial
- Coronary sinus reducer
- Optimal medical therapy
Treatment groups
144 Participants
are divided into 2 treatment groupsSponsors and collaborators
Johannes Gutenberg University Mainz
Lead sponsor
Shockwave Medical, Inc.
Collaborator
Source ClinicalTrials.gov