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 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT01873027
Eligibility Criteria:
Inclusion Criteria:
* Patients with a de novo lesion (in the native coronary circulation) and planned to undergo drug-eluting stent implantation for indications according to the Japan and USA guidelines
* Patients aged between 20 and 85 years old
* Patients who has provided written informed consent
Exclusion Criteria:
* Patients with Acute Myocardial Infarction (AMI) within 3 months
* Patients with cardiogenic shock
* Patients with chronic heart failure
* Patients with renal failure (eGFR \<= 30 ml/min/1.73 m2 or Serum creatinine level \>=1.5mg/dL)
* Patients who are currently enrolled in other clinical trial which has possibility to influence the primary endpoint of OPINION trial.
* Patients planned use of bare metal stent
* Patients with 3-vessel diseases
* Planned surgery within 1 year
* Patient on dialysis
* Target lesion such as:
* Left main coronary artery
* Aorto-Ostial lesion location within 3mm of the aorta junction
* Chronic total occlusion
* Small vessel (reference vessel diameter \<2.5mm)
* Coronary artery bypass graft
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
85 Years
Study:
NCT01873027
Study Brief:
Protocol Section:
NCT01873027