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 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT06300268
Eligibility Criteria:
Inclusion Criteria:
* Age \>18 years
* Gender : All (Males, Females, Transgenders, Non-binary)
* ICF : Patient or legally authorized representative (LAR) agrees to participation by signing the informed consent form.
* Condition - Clinical : Patient with coronary artery disease Eligible for percutaneous coronary intervention (PCI)
* Condition - Angiographic : Patient with coronary artery disease having one or more de novo stenosis lesion in two native coronary artery with a visually estimated diameter stenosis ≥70%
* Condition - Angiographic : Patients with Reference vessel diameter of 2.5 \~ 3.50 mm
* Condition - Angiographic : Patients with lesion length ≤ 36 mm
Exclusion Criteria:
* Ethical : Pregnant and lactating females
* Patients requiring staged procedure
* Condition : Known congestive heart failure (NYHA IV) or left ventricular ejection fraction (LVEF) \<30%
* Condition : Patients with known hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, Sirolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media
* Condition : Current medical condition with a life expectancy of less than 12 months
* Condition : Diagnosis: Acute Myocardial Infarction within 72 hours of Planned Index procedure
* Condition : Patient has current unstable arrhythmias
* Procedural : Patients previously treated with PCI or CABG for any coronary artery lesion revascularization
* Procedural : Patients with Chronic Total Occlusion in two or more vessels
* Procedural : Patients with Ostial lesions (within 5.0mm of vessel origin).
* Procedural : Patients with Bifurcation lesions that include a side branch \>2.0 mm diameter
* Procedural : Unprotected Left Main Coronary Artery lesion
* Condition : Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated in opinion of the treating cardiologist
* Condition : Patients with Cardiogenic shock, systemic bleeding and coagulation disorders, intracranial bleeding, Renal insufficiency requiring dialysis, Acute or chronic renal function (serum creatinine \>2.0mg/dl or 150 µmol/L), peripheral vascular diseases, cancer, etc. and patients who are planning to undergo surgery within 1 year of the index procedure
* Condition : Patients with platelet count \<100.000 cells/mm3 or \>700.000 cells/mm3 or a WBC \<3.000 cells/mm3
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06300268
Study Brief:
Protocol Section:
NCT06300268