Actively Recruiting
A Multicentric Randomized Open Label Controlled Superiority Trial to Evaluate the Effectiveness of a Therapy With a Coronary Sinus Reducer Compared to Guideline-directed Medical Therapy in Patients With Refractory Microvascular Angina
Led by Johannes Gutenberg University Mainz · Updated on 2023-09-28
144
Participants Needed
1
Research Sites
208 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
Researchers are investigating treatments for refractory microvascular angina, a common condition where small vessels in the heart do not work properly, causing chest pain. This trial aims to compare whether using a Coronary Sinus Reducer device plus optimal medical therapy improves symptoms more than medical therapy alone. Microvascular angina affects many patients with chest pain but no major artery blockages, posing challenges for effective treatment and increasing risks of hospitalizations and poor quality of life. The study compares two groups: one receiving optimal medical therapy following European guidelines, including medications like aspirin, statins, beta-blockers, and calcium channel blockers, and the other receiving the same medical therapy plus implantation of the Neovasc Reducer device. This device is placed in the coronary sinus vein via a minimally invasive procedure to improve blood flow to the heart muscle. The trial is randomized and open-label, with careful monitoring of the device implantation success and treatment effects. Participants will be followed for at least six months to assess changes in angina severity using the Canadian Cardiovascular Society angina classification and other questionnaires on quality of life and symptom frequency. Researchers will also track emergency visits, hospitalizations, and adverse events over several years. The study includes detailed clinical assessments and aims to provide evidence on the potential benefits of the device for patients whose symptoms do not improve with medication alone.
CONDITIONS
Brief 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 angina class III-IV despite guideline-directed medical therapy
- Evidence of reversible ischemia on non-invasive testing
- Microvascular disease confirmed by index of microvascular resistances >25 and/or coronary flow reserve <2.0 with fractional flow reserve >0.8
- Willingness and ability to understand, read, and sign informed consent
You will not qualify if you...
- Recent acute coronary syndrome within 3 months
- Recent revascularization by PCI or coronary artery bypass surgery within 6 months
- Recent unsuccessful PCI within 30 days
- Decompensated congestive heart failure or hospitalization due to CHF within 3 months
- Left ventricular ejection fraction less than 30%
- Mean right atrial pressure greater than 15mmHg
- Abnormal coronary sinus anatomy
- Coronary sinus diameter outside 9.5 to 13mm at planned implantation site
- Severe chronic obstructive pulmonary disease
- Severe valvular heart disease
- Pacemaker electrode in the coronary sinus
- Tricuspid valve replacement or repair
- Chronic renal failure with serum creatinine >2mg/dL or on hemodialysis
- Moribund or with life expectancy less than 1 year
- Severe reaction to procedural medications
- Allergy to stainless steel or nickel
- Need for MRI within 8 weeks after implantation
- Contraindication to dual antiplatelet therapy
- Female of childbearing potential without sterilization or menopause within last 12 months
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants in the intervention group undergo implantation of the Coronary Sinus Reducer device through a minimally invasive procedure via the right internal jugular vein.
1 visit (implantation day, in-person)
Duration - 6 months
Participants receive guideline-directed medical therapy as recommended by current clinical guidelines or have the Coronary Sinus Reducer device implanted to manage refractory microvascular angina.
Regular visits for assessments during the 6 months treatment period
Duration - Up to 5 years
Participants are monitored for angina severity, quality of life, adverse events, and cardiac outcomes following treatment.
Visits at 6 months, 1 year, and annually up to 5 years
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
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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