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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Coronary sinus reducer
DeviceThe 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.
Optimal medical therapy
Other interventionGuideline-directed medical therapy
Treatment groups
144 Participants
are divided into 2 treatment groupsGroup A: Optimal medical therapyActive comparator 1 intervention
Group B: Coronary sinus reducerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Canadian Cardiovascular Society angina class by two or more classes
Proportion of patients improving ≥2 CCS angina classes at six months after the implantation followed byoptimal medical therapy (OMT) compared to OMT alone.
Time frame
6 monthsSecondary outcomes
1
Change in angina severity according to the Seattle Angina Questionnaire
change in angina severity as assessed by the Seattle Angina Questionnaire (SAQ-7, range from 0 to 100, with 100 as minimal physical limitation and angina and 0 as maximal limitation and angina) at six months.
Time frame
Six months2
Number of participants with technical success
\- Technical success: in the Reducer group, defined as successful delivery and deployment of the Reducer to the intended site as assessed by the investigator
Time frame
Implantation day3
Procedural success
\- Procedural success: in the Reducer group, defined as technical success and the absence of acute need for clinically-driven intervention to address an Adverse or Serious Adverse Device Effect prior to hospital discharge, as adjudicated by the Clinical Events Committee (CEC)
Time frame
Implantation day4
Frequency of use of sublingual nitrates (times per week)
Use of sublingual nitrates
Time frame
6 months, 1 year, 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johannes Gutenberg University Mainz
Lead sponsor
Shockwave Medical, Inc.
Collaborator
Source ClinicalTrials.gov