NCT05492110

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

April 17, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2026

Completed
Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

2.9 years

First QC Date

August 4, 2022

Last Update Submit

March 31, 2025

Conditions

Refractory AnginaMicrovascular AnginaMicrovascular Coronary Artery DiseaseCoronary DiseaseAngina Pectoris

Keywords

Angina pectorisRefractory anginaMicrovascular anginaCoronary microvascular dysfunctionCoronary sinus reducerChest painCoronary diseaseMyocardial ischaemia

Outcome Measures

Primary Outcomes (3)

  • number of patients consenting to participate in the study.

    Consent rate

    6 months

  • Premature withdrawal rate including reasons for withdrawal

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

    6 months

  • Change in myocardial perfusion

    Change at 6 months post randomisation, compared to baseline, in quantitative myocardial perfusion (global myocardial perfusion reserve \[MPR\]) assessed by cardiac MRI.

    6 months

Secondary Outcomes (7)

  • Canadian Cardiovascular Society (CCS) Angina Score

    6 months

  • Seattle Angina Questionnaire (SAQ) score

    6 months

  • Short-form 36 (SF-36)

    6 months

  • Hospital Anxiety and Depression Scale (HADS)

    6 months

  • 6-minute walk test (6MWT)

    6 months

  • +2 more secondary outcomes

Other Outcomes (4)

  • Change in absolute global myocardial perfusion (ml/min/g) at rest and during adenosine stress (transmural, endocardial, epicardial) from baseline to 6 months post-randomisation

    6 months

  • Change in absolute myocardial perfusion (ml/min/g) at rest and during adenosine stress (transmural, endocardial, epicardial) from baseline to 6 months post-randomisation in the distribution territory of the left coronary circulation.

    6 months

  • Change in global endocardial:epicardial perfusion ratio at rest and after adenosine stress from baseline to 6 months post-randomisation

    6 months

  • +1 more other outcomes

Study Arms (2)

CS Reducer implantation

ACTIVE COMPARATOR
Device: Coronary sinus reducerDiagnostic Test: Invasive coronary physiology

Sham procedure

SHAM COMPARATOR
Other: Sham-procedureDiagnostic Test: Invasive coronary physiology

Interventions

Coronary sinus reducerDEVICE

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.

CS Reducer implantation
Sham-procedureOTHER

Implantation procedure with no device implanted

Sham procedure
Invasive coronary physiologyDIAGNOSTIC_TEST

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

CS Reducer implantationSham procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify 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 \<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)
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

London, SW36NP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Angina PectorisMicrovascular AnginaCoronary DiseaseChest PainCoronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Ranil E de Silva, FRCP, PhD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ranil de Silva, FRCP, PhD

CONTACT

+44 2073518626r.desilva@imperial.ac.uk

Kevin Cheng, BM BCh, MRCP

CONTACT

+44 2073518626kevin.cheng@imperial.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Participants will be randomised and blinded to CS Reducer of sham procedure. All follow-up assessments will be performed by a blinded parallel team to ensure blinded outcomes analysis.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised, double-blinded, sham-controlled pilot study with parallel arms of participants randomised to CS Reducer or sham procedure
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2022

First Posted

August 8, 2022

Study Start

April 17, 2023

Primary Completion

March 6, 2026

Study Completion

March 6, 2026

Last Updated

April 3, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)