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 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT01735656
Eligibility Criteria:
Inclusion Criteria:
1. Patients with age of ≥18 and ≤80 years old.
2. Patients with stable or unstable angina, or NSTEMI.
3. De novo true bifurcation lesions (Medina 0,1,1/1,1,1/1,0,1); MV diameter ≥2.5mm and SB diameter ≥2.25.
4. Lesions suitable for PCI (the SYNTAX score \<32 if lesions located at LM bifurcation).
5. Patients willing to receive all protocol-required evaluations.
6. Patients completely understand the trial requirements and treatment procedures and provide written informed consent before any trial-specific tests or procedures are performed.
Exclusion Criteria:
1. Patients with STEMI (within 24-hour from the onset of chest pain to admission).
2. Lesions not suitable for PCI (the SYNTAX score ≥32 if lesions located at LM bifurcation, or any PCI-related contraindications including patient conditions and/or lesion characteristics).
3. A Chronic total occlusion lesion involved in bifurcation
4. Lesion with severe calcification that required for rotational atherectomy.
5. Patients intolerable to long-term dual anti-platelet therapy.
6. Patients with obvious hematopoietic disorders (e.g., platelet count\< 100×10\^9/L or \>700×10\^9/L, leukocyte count\<3×10\^9/L).
7. Patients with active bleeding and obviously hemorrhagic tendency (e.g., active ulcer, recent ischemic stroke, previous hemorrhagic stroke, intracranial malignant tumors, recent craniocerebral trauma, or any other active bleeding or hemorrhagic tendency with difficult hemostasis
8. Patients with serious renal insufficiency (Scr\<30ml/min) or hepatic insufficiency (ALT≧3 times of normal upper limit), heart failure (NYHA class \>III class).
9. Patients with any other serious medical illness that life expectancy is less than 12 months.
10. Woman with pregnancy or planning to pregnancy
11. Patients with known allergy to the study stent system (sirolimus, everolimus, zotarolimus) or to protocol-required concomitant medications
12. Patients with a planned or planning procedure that may cause non-compliance with the present protocol or confound data interpretation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01735656
Study Brief:
Protocol Section:
NCT01735656