NCT05492110: REMEDY-PILOT

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

Recruiting now NA Last updated 3 April 2025

What this trial tests

NA trial testing Coronary sinus reducer in Refractory Angina in 54 participants. Currently enrolling.

Timeline

17 April 2023

Primary endpoint
6 March 2026

6 March 2026

Quick facts

Lead sponsor	Imperial College London
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	54
Start date	17 April 2023
Primary completion	6 March 2026
Estimated completion	6 March 2026
Sites	1 location across United Kingdom

Drugs / interventions tested

• Coronary sinus reducer
• Sham-procedure
• Invasive coronary physiology

Conditions studied

• Refractory Angina — all drugs for Refractory Angina →
• Microvascular Angina — all drugs for Microvascular Angina →
• Microvascular Coronary Artery Disease — all drugs for Microvascular Coronary Artery Disease →
• Coronary Disease — all drugs for Coronary Disease →

Sponsor

Imperial College London

Who can join

18 and older, any sex, with Refractory Angina or Microvascular Angina. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Refractory angina: mechanisms and stratified treatment in obstructive and non-obstructive chronic myocardial ischaemic syndromes.
   de Silva R, Cheng K, Henry TD, Perera D, et al · · 2025 · cited 5× · PMID 40590516 · DOI 10.1093/eurheartj/ehaf284
2. Ischaemia with no obstructive coronary arteries: a review with focus on the Asian population.
   Soh RY, Low TT, Sia CH, Kong WK, et al · · 2024 · cited 3× · PMID 38973187 · DOI 10.4103/singaporemedj.smj-2023-116
3. Segmental redistribution of myocardial blood flow after coronary sinus reducer implantation demonstrated by quantitative perfusion cardiovascular magnetic resonance.
   Cheng K, Alpendurada F, Bucciarelli-Ducci C, Almeida J, et al · · 2025 · cited 1× · PMID 40021090 · DOI 10.1016/j.jocmr.2025.101868
4. Coronary Sinus Reducer Improves Myocardial Perfusion in a Patient With Angina, Hypertrophic Cardiomyopathy, and Coronary Microvascular Disease.
   Hoole SP, Tweed K, Williams L, Weir-McCall J. · · 2024 · cited 1× · PMID 39582699 · DOI 10.1016/j.cjco.2024.07.011
5. Coronary Sinus Reducer Therapy for Refractory Angina and its Role in Modern Interventional Practice: A Contemporary Review.
   Cheng K, Hill JM, de Silva R. · · 2024 · cited 1× · PMID 39145119 · DOI 10.15420/icr.2023.45
6. Coronary Sinus Reduction for REDUCER-I Patients With Refractory Angina and Angiographically Nonobstructive Coronary Artery Disease.
   de Silva R, van de Hoef TP, van Kuijk JP, Byrne J, et al · · 2026 · PMID 41863985 · DOI 10.1016/j.jacadv.2026.102686
7. Coronary Microvascular Dysfunction in Cardiomyopathies: Insights on Clinical and Prognostic Roles.
   Giacobbe F, Meynet P, Balducci M, Capoccia S, et al · · 2026 · PMID 41789319 · DOI 10.31083/rcm46829
8. Coronary Sinus Reduction for the Treatment of Refractory Angina: What Have We Learned after 70 Years of the Beck Surgery?
   Ziotti SDV, Dourado LOC, Silva R, Al-Lamee R, et al · · 2026 · PMID 41563253 · DOI 10.36660/abc.20250139