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NCT04606459Recruiting

COSIMA: COronary SInus Reducer for the Treatment of Refractory Microvascular Angina

A Multicentric Randomized Open Label Controlled Superiority Trial to Evaluate the Effectiveness of a Therapy With a Coronary Sinus Reducer as Compared to Guideline-directed Medical Therapy in Patients With Refractory Microvascular Angina

Source: ClinicalTrials.gov · Last updated 28 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open

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Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
144 (estimated)
First submitted
18 Oct 2020
Start date
1 Apr 2021
Primary completion date
20 Oct 2025
Lead sponsor
Johannes Gutenberg University Mainz
NCT number
NCT04606459

What you commit to

  • Study type: Interventional
  • Planned participants: 144
  • From 1 Apr 2021 to the primary completion date, 20 Oct 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Recent (within 6 months) revascularization by percutaneous coronary intervention (PCI, stent) or coronary artery by-pass surgery (CABG)
  • Known severe reaction to required procedural medications
  • Contraindication to dual antiplatelet therapy

Other illness

  • Recent (within 3 months) acute coronary syndrome
  • Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the last 3 months
  • 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
  • Known allergy to stainless steel or nickel

Lab values

  • Left ventricular ejection fraction of <30%
  • Chronic renal failure (serum creatinine >2mg/dL), and/or on chronic hemodialysis

Other

  • Subjects presenting at least one of the following criteria will not be enrolled in the trial
  • Recent (within 30 days) unsuccessful PCI
  • 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
  • A pacemaker electrode in the coronary sinus
  • Tricuspid valve replacement or repair
  • Moribund, or with comorbidities limiting life expectancy to less than one year
  • Need for Magnetic Resonance Imaging (MRI) within 8 weeks after reducer implantation
  • Female of childbearing potential (last menstruation within the last 12 months or who did not undergo tubal ligation, ovariectomy or hysterectomy)

Who the study is looking for

  • 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) <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.

Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Center of Cardiology, Cardiology I, university hospital MainzMainzGermanyRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.