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New treatment option for Coronary Microvascular Disease
Official title COSIMA: COronary SInus Reducer for the Treatment of Refractory Microvascular Angina
ClinicalTrials.gov ID: NCT04606459
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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:
- index of microvascular resistances (IMR) \>25 and/or
You likely can't join if
- people 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%
See the full eligibility 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:
- index of microvascular resistances (IMR) \>25 and/or
- coronary flow reserve (CFR) \ 0.8.
- Willingness to participate and ability to understand, read and sign the informed consent document before enrollment in the trial.
- people 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)
The study team makes the final eligibility decision.
Where it's taking place
- Mainz, Rhineland-Palatinate, Germany
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mainz, Rhineland-Palatinate, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.