Coronary Sinus Reducer for treating refractory microvascular angina

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of a Coronary Sinus Reducer in patients with refractory microvascular angina. Participants will be randomly assigned to receive either the device along with optimal medical therapy or optimal medical therapy alone. The primary goal is to determine if there is a significant improvement in angina symptoms, measured by changes in the Canadian Cardiovascular Society (CCS) angina class, after six months. The study aims to address the high prevalence and burden of microvascular disease, which affects a substantial number of patients with angina but no obstructive coronary artery disease.

Why it matters

Who can join: the full rules

Inclusion 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:

  1. index of microvascular resistances (IMR) \>25 and/or
  2. coronary flow reserve (CFR) \<2.0) with fractional flow reserve (FFR)\>0.8.
* Willingness to participate and ability to understand, read and sign the informed consent document before enrollment in the trial.

Exclusion Criteria:

Subjects 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)

Where it's running

• Center of Cardiology, Cardiology I, university hospital Mainz
  Mainz, Rhineland-Palatinate, Germany Recruiting

Study contacts

• Study coordinator: tommaso gori, PI
• Email: tommaso.gori@unimedizin-mainz.de
• Phone: +496131172829

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.