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Refractory AnginaREMEDY-PILOTNCT05492110

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

A study testing Coronary sinus reducer and Invasive coronary physiology in people with Refractory Angina and Microvascular Angina, run by Imperial College London at 1 site in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Coronary sinus reducer and Invasive coronary physiology
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
54 participants
Where
1 siteUnited Kingdom
Study dates
17 Apr 2023to 5 Aug 2026
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age >18 years
  • 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.
  • 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.

Who cannot join

  • 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).
  • 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
  • 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.
  • Clinically or angiographically diagnosed coronary vasospasm
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  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • National Heart and Lung Institute (Brompton Campus), Imperial College London

    London, London, SW36NP

Other trials in United Kingdom

About this study

Official title: REducing Microvascular Dysfunction in Patients With Angina, Ischaemia and unobstructED coronarY Arteries - a PILOT Study

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.

Read the detailed description

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.

Being tested
Coronary sinus reducer, Sham Procedure, Invasive coronary physiology
Keywords
Angina pectoris, Refractory angina, Microvascular angina, Coronary microvascular dysfunction, Coronary sinus reducer, Chest pain, Coronary disease, Myocardial ischaemia, INOCA (ischemia with non obstructive coronary artery disease), ANOCA - angina with non-obstructive coronary arteries
Medical subject headings
Angina Pectoris, Microvascular Angina, Coronary Disease, Chest Pain, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronary sinus reducerDevice

    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 ProcedureOther

    Implantation procedure with no device implanted

  • Invasive coronary physiologyDiagnostic test

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

Study groups in NCT05492110
Study groupRoleWhat they receive
CS Reducer implantationActive comparatorNot described
Receives: Device: Coronary sinus reducer; Diagnostic Test: Invasive coronary physiology
Sham procedureSham comparatorNot described
Receives: Other: Sham Procedure; Diagnostic Test: Invasive coronary physiology

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients consenting to participate in the study

    Consent rate

    Measured: 6 months

  2. Premature withdrawal rate including reasons for withdrawal

    Registry of patients either failing screening or unwilling to consent to full trial

    Measured: 6 months

  3. Change in myocardial perfusion

    Change in segmental endocardial myocardial perfusion reserve (MPR) [ratio of absolute MBF after adenosine stress to rest MBF corrected for rate-pressure product] at 6-months follow-up after CS Reducer compared to a sham procedure.

    Measured: 6 months

Secondary outcomes (9)

  1. ORBITA smartphone application

    Daily angina episodes

    Measured: 6 months

  2. Seattle Angina Questionnaire (SAQ) score

    Change in SAQ score from baseline to 6 months. The Seattle Angina Questionnaire (SAQ) is a disease-specific questionnaire used to quantify patients' symptoms of angina and the extent to which their angina affects their functioning and quality of life. Possible scores range from 0 (daily angina) to 100 (no angina). Lower scores indicate worse angina symptoms.

    Measured: 6 months

  3. Short-form 36 (SF-36)

    Change in SF-36 scores from baseline to 6 months. Validated questionnaire to assess quality of life. 36 items each scored from 0-100 with higher scores indicating a more favourable health state.

    Measured: 6 months

  4. Hospital Anxiety and Depression Scale (HADS)

    Change in HADS score from baseline to 6 months. Scores range from 0 to 21. Normal results are indicated by lower scores. Validated questionnaire to assess psychological wellbeing.

    Measured: 6 months

  5. EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)

    Change in EQ-5D-5L index score from baseline to 6 months. Quality of life assessed using the EQ-5D-5L, a five-domain descriptive system generating an index score from 0 (worst health) to 1 (best health), with higher scores indicating better quality of life.

    Measured: 6 months

  6. Canadian Cardiovascular Society (CCS) Angina Score

    Change in CCS class from baseline to 6 months post-randomisation. The CCS grading system for angina is a clinical tool used by doctors to assess the degree of severity of a patient's angina. Possible scores range from Class 0 (asymptomatic angina) to Class IV (angina at rest).

    Measured: 6 months

  7. 6-minute walk test (6MWT)

    Change in exercise capacity from baseline to 6 months. Distance in metres walked in 6 minutes.

    Measured: 6 months

  8. BORG scale of perceived exertion

    Change in BORG scale from baseline to 6 months. Scores range from 0 to 20 (BORG scale) or 0 to 10 (Modified BORG scale). The higher the self-reported score, the greater perceived exertion.

    Measured: 6 months

  9. Safety events

    Serious adverse events resulting from the CS Reducer procedure

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2022
  2. Study start17 Apr 2023
  3. Primary completion4 Aug 2026
  4. Study completion5 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomised, double-blinded, sham-controlled pilot study with parallel arms of participants randomised to CS Reducer or sham procedure
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05492110
Sponsor's protocol ID
21IC7301
Acronym
REMEDY-PILOT
Status last verified
Aug 2026
First submitted
4 Aug 2022
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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