Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT05492110

Coronary Sinus Reducer Implantation in Patients With Ischaemia and Non-obstructed Coronary Arteries and Coronary Microvascular Dysfunction.

Sponsor: Imperial College London

View on ClinicalTrials.gov

Summary

To demonstrate the feasibility and efficacy of the CS Reducer for the treatment of patients with ischaemia and non-obstructed coronary arteries (INOCA) and coronary microvascular dysfunction (CMD) and through a nested mechanistic substudy investigate the physiological responses in the coronary microcirculation responsible for changes in myocardial perfusion.

Official title: REducing Microvascular Dysfunction in Patients With Angina, Ischaemia and unobstructED coronarY Arteries - a PILOT Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-04-17

Completion Date

2026-03-06

Last Updated

2025-04-03

Healthy Volunteers

Conditions

Refractory Angina Microvascular Angina Microvascular Coronary Artery Disease Coronary Disease Angina Pectoris

Interventions

DEVICE

Coronary sinus reducer

The Neovasc coronary sinus reducer is an hourglass-shaped stainless steel device inserted percutaneously into the coronary sinus and currently indicated for the treatment of refractory angina.

OTHER

Sham-procedure

Implantation procedure with no device implanted

DIAGNOSTIC_TEST

Invasive coronary physiology

Invasive coronary physiology assessment as part of REMEDY-MECH mechanistic substudy

Inclusion Criteria: 1. Age \>18 years 2. Ongoing symptomatic angina, CCS Class II-IV, for ≥3 months despite background treatment with at least two anti-anginal drug at the maximal tolerated dose. 3. Patients willing to consider no change in anti-anginal drug treatment for the duration of their participation in the trial. 4. Unobstructed coronary arteries with ≤50% epicardial stenoses demonstrated on coronary angiography. 5. Stress-induced hypoperfusion on CMR (Global MPR ≤ 2.2). 6. Willingness to comply with the specified follow-up evaluation and to be contactable during the period of the trial. 7. Understands the nature of the trial procedures and provides written informed consent. Exclusion Criteria: 1. Epicardial CAD in a main coronary artery (stenoses \>50%, RFR≤0.92 or FFR≤0.80), coronary artery bypass grafting, or myocardial infarction (MI). 2. Previous PCI within 6 months 3. PCI with stent insertion for acute MI or chronic total occlusion (CTO) 4. Abnormal coronary sinus anatomy (tortuosity, aberrant branch, persistent left superior vena cava) 5. Coronary sinus diameter at site of implant \<9.5mm or \>13mm 6. Mean right atrial pressure \<15mmHg at time of implantation 7. Any structural heart disease including left ventricular hypertrophy; cardiomyopathy; severe valvular heart disease; previous valve replacement; myocardial bridge on angiography; LVEF\<45% by CMR. 8. Clinically or angiographically diagnosed coronary vasospasm 9. Previous hospitalisation for decompensated heart failure 10. Pacemaker or defibrillator electrode in the right atrium, right ventricle or coronary sinus 11. Documented arrhythmia requiring planned implantation of a permanent pacemaker or defibrillator 12. Chronic kidney disease (creatinine \>200 micromol/L; established on renal replacement therapy; functioning renal transplant) 13. Haemoglobin \<80g/L 14. Contraindications to receiving dual antiplatelet therapy 15. Severe chronic obstructive pulmonary disease (FEV1 \<55% predicted) 16. Moribund patients with life expectancy \< 1year 17. Known allergy to nickel or steel 18. Current enrolment in another investigational device or drug trial 19. Contraindications to CMR or receiving intravenous adenosine 20. Pregnancy

Locations (1)

National Heart and Lung Institute (Brompton Campus), Imperial College London

London, United Kingdom