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 @ 2:14 PM
Ignite Modification Date:
2025-12-24 @ 2:14 PM
NCT ID:
NCT02932995
Eligibility Criteria:
Inclusion Criteria:
1. Patient
* Age \>=19 years
* Clinically indicated to invasive coronary angiography
* Patient capable and willing of giving written informed consent
2. Angiographic
* coronary artery disease confined to native coronary artery
* \>50% diameter stenosis by invasive coronary angiography
* reference diameter 2.5-4.0mm, lesion length ≤30 mm
Exclusion Criteria:
1. Patient
* Inability to provide written informed consent
* Serious comorbidity which may affect the trial by decision of investigators
* Prior CABG to target vessel
* Congestive heart failure with NYHA Class III or IV or left ventricular ejection fraction less than 30%
* Prior ST elevation myocardial infarction within 72 hours from the procedure
* Hemodynamic or electrical instability including shock
* Serious coronary artery spasm, unrelated to catheter
* Pregnancy or possible pregnant status
* Allergy to iodinated contrast agent
* Serum creatinine \>=1.7 mg/dL or creatinine clearance \<= 30 ml/min
* ST elevation myocardial infarction
2. Angiographic (OCT)
* Left main disease
* Severely calcified lesion
* Severely tortuous, or TIMI flow grade 0 or 1 by angiography, or inappropriate for OCT procedure by investigators' decision
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT02932995
Study Brief:
Protocol Section:
NCT02932995