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

NCT04606459 | Recruiting DMC

• 1 other identifier: 2020-15363
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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

Coronary Microvascular Disease; Refractory Angina

Outcome Measures

Primary Outcomes (1)

• Change in Canadian Cardiovascular Society angina class by two or more classes

  Proportion of patients improving ≥2 CCS angina classes at six months after the implantation followed byoptimal medical therapy (OMT) compared to OMT alone.

  6 months

Secondary Outcomes (11)

• Change in angina severity according to the Seattle Angina Questionnaire

  Six months

• Number of participants with technical success

  Implantation day

• Procedural success

  Implantation day

• Frequency of use of sublingual nitrates (times per week)

  6 months, 1 year, 5 years

• Parameters of angina and quality of life

  at 6 months

Study Arms (2)

Optimal medical therapy

ACTIVE COMPARATOR

Optimal medical therapy consisting of acetyl salicylic acid, statins, beta-blockers, calcium channel-antagonists, ranolazine will be administered at the discretion of the physician as recommended by the most recent European Society of Cardiology (ESC) guidelines. Long-acting nitrates will not be administered unless for patients with fractional flow reserve (FFR)\<0.8 or with previously reported good response. Short-acting nitrates may be administered in patients in whom concomitant epicardial spasm is suspected, but they have no documented effect on microvascular angina.

Other: Optimal medical therapy

Coronary sinus reducer

EXPERIMENTAL

The device being studied is the Neovasc Reducer™ System. Each patient in the Reducer group will be implanted with a single Reducer according to the instructions for use.

Device: Coronary sinus reducer

Interventions

Coronary sinus reducer DEVICE

The Reducer System comprises the Reducer device (Reducer) pre-mounted on the Reducer Balloon Catheter. The Reducer System is available in one model size. The Reducer is a sterile, single-use, implantable device designed to establish a narrowing in the coronary sinus (CS) and is intended to improve perfusion to ischemic myocardium in the presence of reversible ischemic heart disease to alleviate the symptoms of refractory angina. The device is implanted percutaneously through the right internal jugular vein into the CS. The Reducer is pre-mounted (crimped) on the Reducer Balloon Catheter which, after inflation, causes device expansion and apposition with the vessel wall. The balloon catheter is then deflated and removed from the CS, leaving the device permanently implanted.

Coronary sinus reducer

Optimal medical therapy OTHER

Guideline-directed medical therapy

Optimal medical therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead
• Shockwave Medical, Inc.: collaborator

Study Sites (1)

Center of Cardiology, Cardiology I, university hospital Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

RECRUITING

MeSH Terms

Conditions

Microvascular Angina; Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

tommaso gori, PI

CONTACT

+496131172829; tommaso.gori@unimedizin-mainz.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Given the nature of the intervention, there is not possibility to use a blinded design
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: In the current randomized, controlled, parallel-groups trial, patients will be randomized to guideline-directed optimal medical therapy with coronary sinus Reducer (Neovasc Reducer™ System) implantation or guideline-directed medical therapy alone.

Study Record Dates

• First Submitted: October 18, 2020
• First Posted: October 28, 2020
• Study Start: April 1, 2021
• Primary Completion: October 20, 2025
• Study Completion (Estimated): October 20, 2029
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

DE (1)