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 @ 4:31 AM
Ignite Modification Date:
2025-12-25 @ 4:31 AM
NCT ID:
NCT02014818
Eligibility Criteria:
Inclusion Criteria:
* Patients having at least one de novo lesion in a coronary artery in whom PCI with a DES is indicated
* Patients aged 20 to less than 85 years at the time of informed consent
* Patients who have provided informed consent written by themselves
* Patients who are able to undergo OCT examinations of the site of stent placement at 1 or 3 months and at 12 months
Exclusion Criteria:
* If it is judged difficult to perform clinical and angiographic follow-up at 12 months (considering the patient's remote place of residence, etc.)
* Patients with acute myocardial infarction (AMI)
* Patients in a state of shock
* Patients with cardiac failure
* Patients having a culprit lesion in the left main coronary artery trunk
* Patients having a lesion with a reference vessel diameter of less than 2.0 mm or 4.5 mm or larger by visual estimate
* Patients having an in-stent restenosis lesion as the culprit lesion
* Patients having chronic renal failure with a serum creatinine level of 2.0 mg/dL or higher at a screening visit
* Patients on hemodialysis
* Cancer patients with a life expectancy of less than 2 years
* Patients who are scheduled to undergo elective surgery requiring discontinuation of antiplatelet therapy within the next 3 months
* Pregnant women or women expected to become pregnant
* Patients with a history of adverse reactions to aspirin or clopidogrel (however, it is acceptable to enroll patients in whom the safety of ticlopidine has been confirmed, even if they have a history of adverse reactions to clopidogrel)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
84 Years
Study:
NCT02014818
Study Brief:
Protocol Section:
NCT02014818