Actively Recruiting
COSIMA: COronary SInus Reducer for the Treatment of Refractory Microvascular Angina
Led by Johannes Gutenberg University Mainz · Updated on 2023-09-28
144
Participants Needed
1
Research Sites
446 weeks
Total Duration
On this page
Sponsors
J
Johannes Gutenberg University Mainz
Lead Sponsor
S
Shockwave Medical, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
COSIMA: COronary SInus Reducer for the Treatment of Refractory Microvascular Angina
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 85 years
- Chronic coronary syndrome with refractory angina CCS class III-IV despite guideline-directed medical therapy
- Evidence of reversible ischemia on non-invasive testing
- Diagnosis of microvascular disease confirmed by invasive tests showing either an index of microvascular resistances (IMR) >25 or coronary flow reserve (CFR) <2.0 with fractional flow reserve (FFR) >0.8
- Ability and willingness to understand and sign informed consent
You will not qualify if you...
- Recent acute coronary syndrome within 3 months
- Recent coronary revascularization by PCI or CABG within 6 months
- Unsuccessful PCI within 30 days
- Decompensated congestive heart failure or hospitalization for CHF in the last 3 months
- Left ventricular ejection fraction less than 30%
- Mean right atrial pressure greater than 15mmHg
- Abnormal coronary sinus anatomy preventing device implantation
- Coronary sinus diameter outside 9.5mm to 13mm range at implantation site
- Severe chronic obstructive pulmonary disease with FEV1 less than 55% predicted
- Severe valvular heart disease
- Presence of pacemaker electrode in the coronary sinus
- Tricuspid valve replacement or repair
- Chronic renal failure with serum creatinine over 2mg/dL or on hemodialysis
- Life expectancy less than one year due to comorbidities
- Known severe reactions to procedural medications
- Allergy to stainless steel or nickel
- Need for MRI within 8 weeks after device implantation
- Contraindication to dual antiplatelet therapy
- Female of childbearing potential without permanent sterilization or last menstruation within 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Center of Cardiology, Cardiology I, university hospital Mainz
Mainz, Rhineland-Palatinate, Germany, 55131
Actively Recruiting
Research Team
T
tommaso gori, PI
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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