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 @ 1:43 PM
Ignite Modification Date:
2025-12-24 @ 1:43 PM
NCT ID:
NCT07098195
Eligibility Criteria:
Inclusion Criteria:
1. Age more than 18 years
2. All Genders (Males, Females, Transgenders, Non binary)
3. Patient or legally authorized representative (LAR) agrees to participate by signing the informed consent form.
4. Patient with coronary artery disease eligible for percutaneous coronary intervention (PCI) as per regional or hospital's standard practices guidelines for PCI (For Europe, as per ESC guidelines)
5. Patient with coronary artery disease having one or more de novo or in - stent stenosis lesions in native coronary artery with a visually estimated diameter stenosis ≥70%.
6. Patients with Reference vessel diameter of 2.0 to 4.5 mm
7. Patients with lesion length less than 48 mm
Exclusion Criteria:
1. Pregnant and lactating females
2. Candidates for emergency bypass Surgery
3. Patients corresponding to the criteria of a vulnerable population (Vulnerable subjects, including patients who are unable to fully understand all aspects of the investigation, patients who could be manipulated or unduly influenced, patients lacking capacity in the informed consent procedure and patients with dementia and cognitive impairment, patients under social security, imprisonment etc.)
4. Known congestive heart failure (NYHA IV) or left ventricular ejection fraction (LVEF) less than 30 Percent
5. Patients with known hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, Everolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media
6. Current medical condition with a life expectancy of less than 12 months
7. Patient who have current unstable arrhythmias
8. Patient previously undergone CABG.
9. Left Main Coronary Artery lesion
10. Patients with Cardiogenic shock, systemic bleeding and coagulation disorders, intracranial bleeding, Renal insufficiency requiring dialysis, Acute or chronic renal dysfunction (serum creatinine \>2.0mg/dl or 150 μmol/L), peripheral vascular diseases, cancer, etc. and patients who are planning to undergo surgery within 360 days of the index procedure
11. 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
Maximum Age:
99 Years
Study:
NCT07098195
Study Brief:
Protocol Section:
NCT07098195