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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Coronary sinus reducer
  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.
• Другое Sham-procedure
  Implantation procedure with no device implanted
• Диагностический тест Invasive coronary physiology
  Invasive coronary physiology assessment as part of REMEDY-MECH mechanistic substudy

Первичные конечные точки

• number of patients consenting to participate in the study. [Срок оценки: 6 months]
• Premature withdrawal rate including reasons for withdrawal [Срок оценки: 6 months]
• Change in myocardial perfusion [Срок оценки: 6 months]

Вторичные конечные точки (7)

• Canadian Cardiovascular Society (CCS) Angina Score [Срок оценки: 6 months]
• Seattle Angina Questionnaire (SAQ) score [Срок оценки: 6 months]
• Short-form 36 (SF-36) [Срок оценки: 6 months]
• Hospital Anxiety and Depression Scale (HADS) [Срок оценки: 6 months]
• 6-minute walk test (6MWT) [Срок оценки: 6 months]
• BORG scale of perceived exertion [Срок оценки: 6 months]
• Safety events - rate of major adverse events [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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)
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Великобритания · 1 центр

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

Идентификаторы

NCT: NCT05492110 · 21IC7301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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