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:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2025-12-25 @ 2:56 AM
NCT ID:
NCT06088433
Eligibility Criteria:
Inclusion Criteria:
1. CHD patients aged 18-80 with clear indications for PCI, regardless of gender;
2. Received DCB treatment with only one small coronary artery (diameter 2.0-2.75mm);
3. High risk of bleeding (ARC high risk criteria for bleeding): Meets at least one main criterion (use of anticoagulants, liver dysfunction, tumors, history of gastrointestinal bleeding, history of peptic ulcers, creatinine clearance rate\<30mL/min, hemoglobin\<11g/L, platelet count\<100 × 109/L) or 2 sub criteria (age ≥ 75 years old, creatinine clearance rate\<60mL/min, history of stroke/TIA, hemoglobin 11-12.9g/L for males or 11-11.9g/L for females);
4. Willing to participate in trials and complete follow-up;
5. Signed an informed consent form approved by the Ethics Committee;
Exclusion Criteria:
1. Simultaneously or plan to perform other coronary PCI procedures in batches, including stent implantation, DCB treatment for non-small vessel lesions, and DCB treatment for in stent restenosis lesions.
2. High ischemic risk: a. ACS within 1 year; b. Perform stent implantation or CABG surgery within 1 year; c. Double or multi vessel lesions rearched incomplete revascularization; d. In addition to the target lesions for DCB intervention, there are other stenosis ≥ 90%, regardless of whether PCI is planned or not;
3. Anticoagulant drugs are required for atrial fibrillation/deep vein thrombosis (including pulmonary embolism)/mechanical valve implantation;
4. Cardiomyopathy (HCM/DCM/RCM);
5. Severe ventricular arrhythmias requires radiofrequency ablation or ICD implantation;
6. Chronic obstructive pulmonary disease (bronchial asthma, chronic bronchitis, emphysema, pulmonary heart disease);
7. Serious infectious diseases, including active hepatitis B, hepatitis C or AIDS patients;
8. Blood system diseases with coagulation disorders such as thrombocytopenia, leukemia, and hemophilia;
9. Thrombotic diseases such as antiphospholipid antibody syndrome;
10. Cognitive impairment;
11. Not willing to participate in experiments or cooperate with follow-up;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06088433
Study Brief:
Protocol Section:
NCT06088433