Coronary Sinus Reducer for Angina Without Blocked Arteries

Coronary Sinus Reducer in Patients With Angina With no Obstructive Coronary Disease: a Prospective Single-arm Study

This trial tests whether placing a coronary sinus reducer device can relieve angina in people who have chest pain but no significant coronary artery blockages and confirmed microvascular dysfunction.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Medical University of Warsaw (other)
• Locations: 1 site (Warsaw)
• Trial ID: NCT07010029 on ClinicalTrials.gov

What this trial studies

The trial implants a coronary sinus reducer to narrow the coronary sinus and raise venous pressure in the heart, aiming to alter myocardial perfusion for symptom relief. Participants must have stable angina without significant epicardial stenosis and invasive confirmation of coronary microvascular dysfunction (CFR ≤ 2.5 or IMR ≥ 25) after at least three months of maximal antianginal therapy. Key exclusions include vasospastic angina, significant valvular disease, severe left ventricular dysfunction (EF ≤ 30%), recent acute coronary syndrome or revascularization, and other conditions that increase procedural risk. The study will track changes in symptoms and microvascular physiological indices, building on limited observational data suggesting benefit.

Who should consider this trial

Good fit: Ideal candidates are adults with stable angina, no significant coronary artery stenosis, invasive-confirmed coronary microvascular dysfunction (CFR ≤ 2.5 or IMR ≥ 25), and persistent symptoms despite maximal antianginal therapy for at least three months.

Not a fit: Patients with vasospastic angina, severe valvular disease, significant heart failure (EF ≤ 30%), recent acute coronary events, permanent right-sided pacing/defibrillator leads, or other listed exclusions are unlikely to benefit from this device.

Why it matters

Potential benefit: If successful, the device could reduce angina symptoms and improve quality of life for patients with microvascular angina who have no options left from medications.

How similar studies have performed: Observational studies and prior use of the coronary sinus reducer in patients with obstructive coronary disease have reported symptomatic improvement, but randomized evidence in microvascular angina is limited.

Eligibility criteria

Inclusion Criteria:

* Stable angina symptoms without significant obstruction of coronary artery (defined as coronary artery stenosis diameter ≤ 50% or coronary artery stenosis diameter \>50% and ≤70% with FFR\>0.8), with coronary microvascular dysfunction confirmed in invasive test (defined as coronary flow reserve ≤ 2.5 or index of microvascular resistance ≥ 25)
* No future options for antianginal therapy (maximum antianginal therapy for at least three months)

Exclusion Criteria:

* Vasospastic angina (positive test with acetylcholine),
* Evidence of cardiac ischemia,
* Coronary flow limiting myocardial bridge,
* Severe valvular disease
* Hospitalization for acute heart failure \< 3 months
* Hypertrophic cardiomyopathy,
* Ejection fraction ≤ 30%,
* Permanent pacemaker or defibrillator leads in the right heart,
* Recent acute coronary syndrome \< 6 months,
* Recent revascularization \< 2 months,
* Right atrial pressure of 15 mmHg or higher,
* Severe renal impairment,
* Indication for cardiac resynchronization therapy,
* Pregnancy,
* Life expectancy of less than 1 year,
* Inclusion in another clinical trial

Where this trial is running

Warsaw

• Medical University of Warsaw — Warsaw, Poland (RECRUITING)

Study contacts

• Study coordinator: Mariusz Tomaniak, Professor

Conditions: Angina With No Obstructive Coronary Artery Disease, ANOCA, Coronary Sinus Reducer, CFR, IMR, Angina, CSR, Diastolic Dysfunction