NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT05492110

Active Not RecruitingNA

Sponsor: Imperial College London

Conditions: Refractory Angina, Microvascular Angina, Microvascular Coronary Artery Disease, Coronary Disease, Angina Pectoris

Interventions: Coronary sinus reducer, Sham Procedure, Invasive coronary physiology

Countries: United Kingdom

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 drugs 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), percutaneous coronary intervention (PCI; within previous 6 months, stent insertion for acute Type 1 MI or chronic total occlusion (CTO)), coronary artery bypass grafting, or confirmed Type 1 myocardial infarction (MI).
2. Abnormal coronary sinus anatomy (tortuosity, aberrant branch, persistent left superior vena cava)
3. Coronary sinus diameter unsuitable for device implantation at operator discretion
4. Mean right atrial pressure \>15mmHg at time of implantation
5. Structural heart disease including left ventricular hypertrophy with raised LV mass index; cardiomyopathy; severe valvular heart disease; previous valve replacement; significant myocardial bridge on angiography; LVEF\<45% by CMR.
6. Clinically or angiographically diagnosed coronary vasospasm
7. Previous hospitalisation for decompensated heart failure
8. Pacemaker or defibrillator electrode in the right atrium, right ventricle or coronary sinus
9. Documented arrhythmia requiring planned implantation of a permanent pacemaker or defibrillator
10. Chronic kidney disease (creatinine \>200 micromol/L; established on renal replacement therapy; functioning renal transplant)
11. Haemoglobin \<80g/L
12. Contraindications to receiving dual antiplatelet therapy
13. Severe chronic obstructive pulmonary disease (FEV1 \<55% predicted)
14. Moribund patients with life expectancy \< 1year
15. Known allergy to nickel or steel
16. Current enrolment in another investigational device or drug trial
17. Contraindications to CMR or receiving intravenous adenosine
18. Pregnancy

Locations (1)

London, London, United Kingdom