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New treatment option for Refractory Angina
Official title Coronary Sinus Reducer Implantation in Patients With Ischaemia and Non-obstructed Coronary Arteries and Coronary Microvascular Dysfunction.
ClinicalTrials.gov ID: NCT05492110
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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).
You likely can't join if
- 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 \ 13mm
- Mean right atrial pressure \<15mmHg at time of implantation
See the full eligibility criteria
- 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.
- 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 \ 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
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.