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 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT04465669
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years;
* Patients with symptoms of stable angina and/or presence of a positive functional test for ischemia;
* Patient is eligible for percutaneous coronary intervention (PCI);
* Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee of the respective clinical site.
Exclusion Criteria:
* Target lesion involving a bifurcation with a side branch ≥2.0 mm in diameter;
* Target lesion located in the left main stem;
* Target lesion is located or supplied by an arterial or venous bypass graft;
* Lesion located very distally, difficult to be imaged by OCT;
* Co-morbidities that could interfere with completion of study procedures, or life expectancy less than 1 year;
* Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study;
* Patient underwent target vessel revascularization with a DES;
* Patient presenting with acute myocardial infarction with ST elevation;
* Cerebrovascular accident within the past 12 months;
* Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl);
* Patient receiving oral anticoagulants
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04465669
Study Brief:
Protocol Section:
NCT04465669