Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07324720
Eligibility Criteria:
Inclusion Criteria:
① Patients aged 19 years or older
② Patients with moderate to severe coronary artery stenosis identified on coronary angiography:
A. Diameter stenosis of 50%-90% by visual estimation B. De novo lesions (newly developed lesions) C. Reference vessel diameter ≥ 2.5 mm by visual estimation
③ Patients with either clinically high-risk features for recurrent ischemic events or complex high-risk lesions identified on angiography:
A. Clinically high-risk features i. Medically treated diabetes mellitus ii. Chronic kidney disease (≥ Stage 3B, eGFR \< 45 mL/min/1.73 m²) iii. Acute coronary syndrome (ACS) iv. Previous myocardial infarction (MI)
B. Complex high-risk lesions i. True bifurcation lesions ii. Calcified lesions (moderate to severe calcification on angiography) iii. Diffuse long lesions (≥ 30 mm in length) iv. Multivessel disease v. Multiple lesions (≥ 3 lesions)
④ Patients who can verbally demonstrate an understanding of the risks, benefits, and alternative treatments of invasive physiologic or imaging assessment and PCI
⑤ Patients who agree to the study protocol and clinical follow-up plan, voluntarily decide to participate, and provide written informed consent to participate in this clinical trial
Exclusion Criteria:
* Hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, prasugrel, ticagrelor, adenosine, or nicorandil
* Hemodynamic instability requiring mechanical circulatory support (ECMO or IABP)
* Moderate or severe stenosis of the left main coronary artery (diameter stenosis \> 50%)
* History of coronary artery bypass grafting (CABG)
* Severe asthma or severe chronic obstructive pulmonary disease (COPD) ⑥ Active bleeding
⑦ Major gastrointestinal or genitourinary bleeding within the previous 3 months
⑧ Bleeding diathesis or known coagulopathy, including a history of heparin-induced thrombocytopenia (HIT)
⑨ Life expectancy \< 2 years due to non-cardiovascular comorbidities
⑩ Inability to provide signed informed consent
⑪ Any condition deemed by the investigator to make the patient unsuitable for this clinical trial or likely to increase study-related risks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT07324720
Study Brief:
Protocol Section:
NCT07324720