Multisensor Wireless Pressure Microcatheter For Microvascular Function Assessment In ANOCA/INOCA Patients: A Prospective, Multicenter, Single-Group Target Value Study

Multisensor Wireless Pressure Microcatheter For Microvascular Function Assessment In ANOCA/INOCA Patients: A Prospective, Multicenter, Single-Group Target Value Study

This study aims to evaluate the sensitivity and specificity of a multi-sensor wireless pressure microcatheter for the diagnosis of CMD in patients with ANOCA/INOCA, using quantitative myocardial perfusion imaging of cardiac magnetic resonance (CMR) as a reference.

This is a prospective, multicenter, single-group target value study, which aims to enroll patients with angina symptoms or objective evidence of myocardial ischemia, whose coronary angiography visual assessment shows a diameter stenosis of <50% and an FFR >0.8 (or cRR >0.89).

Inclusion Criteria:

1. Age ≥ 18 years, gender not limited;
2. Symptoms of angina pectoris, or objective evidence of myocardial ischemia (e.g., electrocardiogram, myocardial injury markers, etc.);
3. Visual assessment of coronary angiography shows diameter stenosis < 50% and FFR > 0.8 (or cRR > 0.89);
4. Microvascular function assessment is planned;
5. Agree to participate in this clinical study and voluntarily sign the informed consent form.

Exclusion Criteria:

1. Acute myocardial infarction, PCI, CABG, or valvular surgery following angiography within the past 30 days;
2. Severe valvular disease requiring surgical or interventional treatment;
3. Chest pain with known non-ischemic causes (e.g., pericarditis, pulmonary hypertension, esophageal spasm);
4. Contraindications to CMR (e.g., certain types of pacemakers or defibrillators, severe claustrophobia);
5. Clear contraindications to adenosine and ATP use (e.g., second- or third-degree atrioventricular block, sick sinus syndrome, severe asthma, systolic blood pressure below 90 mmHg);
6. Renal insufficiency (eGFR ≤ 45 mL/min/1.73 m2) or currently undergoing dialysis;
7. Severe heart failure or LVEF ≤ 35%;
8. Severe organ disease or life expectancy less than 2 years;
9. Known to be participating in other drug or device clinical trials that have not yet met the primary endpoint;
10. Other investigators deem the candidate unsuitable for this clinical trial.