Coronary Sinus Reducer Implantation in Patients With Ischaemia and Non-obstructed Coronary Arteries and Coronary Microvascular Dysfunction.
REducing Microvascular Dysfunction in Patients With Angina, Ischaemia and unobstructED coronarY Arteries - a PILOT Study
Imperial College London
54 participants
Apr 17, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- Age \>18 years
- 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.
- Patients willing to consider no change in anti-anginal drug treatment for the duration of their participation in the trial.
- Unobstructed coronary arteries with ≤50% epicardial stenoses demonstrated on coronary angiography.
- Stress-induced hypoperfusion on CMR (Global MPR ≤ 2.2).
- Willingness to comply with the specified follow-up evaluation and to be contactable during the period of the trial.
- Understands the nature of the trial procedures and provides written informed consent.
Exclusion Criteria20
- Epicardial CAD in a main coronary artery (stenoses \>50%, RFR≤0.92 or FFR≤0.80), coronary artery bypass grafting, or myocardial infarction (MI).
- Previous PCI within 6 months
- PCI with stent insertion for acute MI or chronic total occlusion (CTO)
- Abnormal coronary sinus anatomy (tortuosity, aberrant branch, persistent left superior vena cava)
- Coronary sinus diameter at site of implant \<9.5mm or \>13mm
- Mean right atrial pressure \<15mmHg at time of implantation
- Any structural heart disease including left ventricular hypertrophy; cardiomyopathy; severe valvular heart disease; previous valve replacement; myocardial bridge on angiography; LVEF\<45% by CMR.
- Clinically or angiographically diagnosed coronary vasospasm
- Previous hospitalisation for decompensated heart failure
- Pacemaker or defibrillator electrode in the right atrium, right ventricle or coronary sinus
- Documented arrhythmia requiring planned implantation of a permanent pacemaker or defibrillator
- Chronic kidney disease (creatinine \>200 micromol/L; established on renal replacement therapy; functioning renal transplant)
- Haemoglobin \<80g/L
- Contraindications to receiving dual antiplatelet therapy
- Severe chronic obstructive pulmonary disease (FEV1 \<55% predicted)
- Moribund patients with life expectancy \< 1year
- Known allergy to nickel or steel
- Current enrolment in another investigational device or drug trial
- Contraindications to CMR or receiving intravenous adenosine
- Pregnancy
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Interventions
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.
Implantation procedure with no device implanted
Invasive coronary physiology assessment as part of REMEDY-MECH mechanistic substudy
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05492110