At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Coronary sinus reducer (device), Sham Procedure (other), Invasive coronary physiology (diagnostic test)
- How long the study runs
- Study runs about 40 months (dates as stated)
- About the drug or intervention
- Coronary sinus reducer — device: The Shockwave Reducer is an hourglass-shaped stainless steel device inserted percutaneously into the coronary sinus and currently indicated for the treatment of refractory angina. · Sham Procedure — other: Implantation procedure with no device implanted · Invasive coronary physiology — diagnostic test: Invasive coronary physiology assessment as part of REMEDY-MECH mechanistic substudy
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 54
- Started
- 2023-04-17
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for refractory angina
- • NA - 54 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with refractory angina
Where?
- • London - National Heart and Lung Institute (Brompton Campus), Imperial College London
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Age \>18 years
- ✓Ongoing causing symptoms angina, CCS Class II-IV, for ≥3 months despite background treatment with at least two...
- ✓Patients willing to consider no change in anti-anginal drug treatment for the duration of their participation in the...
- ✓Unobstructed coronary arteries with ≤50% epicardial stenoses demonstrated on coronary angiography.
- ✓Stress-induced hypoperfusion on CMR (Global MPR ≤ 2.2).
Who cannot take part
- ✗Abnormal coronary sinus anatomy (tortuosity, aberrant branch, persistent left superior vena cava)
- ✗Coronary sinus diameter unsuitable for device implantation at operator discretion
- ✗Mean right atrial pressure \>15mmHg at time of implantation
- ✗Clinically or angiographically diagnosed coronary vasospasm
- ✗Previous hospitalisation for decompensated heart failure
See the full criteria
Where Is This Study? (1 UK site)
National Heart and Lung Institute (Brompton Campus), Imperial College London
London SW36NP, United Kingdom