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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-17

Study Completion Date

2026-03-06

Brief Summary

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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.

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Detailed Description

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Symptomatic angina in patients with ischaemia and non-obstructed coronary arteries (INOCA) is common and associated with increased morbidity and adverse outcomes. Myocardial ischaemia often arises from coronary microvascular dysfunction (CMD). Current treatments are limited, and novel evidence-based therapies are needed to address this large unmet clinical need. The Coronary Sinus Reducer (CS Reducer) is a new treatment for refractory angina, which creates a focal narrowing in the coronary sinus that increases back pressure and redistributes blood into ischaemic myocardium at the level of the microcirculation. However the precise mechanism remains unknown. This study will be a randomised double-blinded sham-controlled pilot study (REMEDY-PILOT) to confirm acceptability of CS Reducer implantation, demonstrate feasibility to recruit and quantify its effect on myocardial perfusion. A nested mechanistic substudy within REMEDY-PILOT will test the hypothesis that CS Reducer implantation alters measures of invasive coronary microcirculatory physiology as the mechanistic basis for observed changes in quantitative CMR stress perfusion, symptoms and quality of life.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised, double-blinded, sham-controlled pilot study with parallel arms of participants randomised to CS Reducer or sham procedure

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Participants will be randomised and blinded to CS Reducer of sham procedure. All follow-up assessments will be performed by a blinded parallel team to ensure blinded outcomes analysis.

Study Groups

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CS Reducer implantation

Group Type ACTIVE_COMPARATOR

Coronary sinus reducer

Intervention Type DEVICE

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.

Invasive coronary physiology

Intervention Type DIAGNOSTIC_TEST

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

Sham procedure

Group Type SHAM_COMPARATOR

Sham-procedure

Intervention Type OTHER

Implantation procedure with no device implanted

Invasive coronary physiology

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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.

Intervention Type DEVICE

Sham-procedure

Implantation procedure with no device implanted

Intervention Type OTHER

Invasive coronary physiology

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No