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:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-24 @ 9:12 PM
NCT ID:
NCT03452904
Eligibility Criteria:
Inclusion Criteria:
* Clinical Criteria:
1. Patients with age \>= 18 years old
2. Patients with coronary artery disease is confirmed by angiography
3. Patients with angina (CCS class II-IV) or documented ischemia evidence with ECG or ECT
4. Patients agree to sign the informed consent
* Angiographic Criteria:
1. In suit coronary lesions
2. Reference diameters of target vessels by visual estimation from 2.5 mm to 3.5 mm and \< 28 mm in length
3. Lesion diameter stenosis \>= 70% by visual estimation or \>= 50% with objective ischemia evidence (exercise stress testing, ECT or FFR\< 0.8)
Exclusion Criteria:
* Clinical Criteria:
1. Patients with STEMI \<= 1 week
2. Patients with LVEF \< 30%
3. Patients with bleeding diathesis or known anticoagulation dysfunction
4. Patients with medical history regarding of intracranial tumor, aneurysm, arteriovenous malformation or cerebral apoplexy; stroke or TIA within 6 months; gastrointestinal hemorrhage within 2 months; major surgery within 6 weeks; recent or known platelet \< 100,000/mm3 or hemoglobin \< 10 g/dL
5. Patients with planed selective operation probably leading to stopping using ADP receptor antagonists in advance
6. Patients with life expectancy is less than 1 year because of combined comorbidity of other system
* Angiographic Criteria:
1. Acute thrombotic lesions
2. Left main coronary artery lesions
3. Severe intima tear lesions
4. Coronary artery bypass grafts lesions
5. In-stent restenosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03452904
Study Brief:
Protocol Section:
NCT03452904