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 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT04710368
Eligibility Criteria:
Inclusion criteria:
* Men or women aged 18 years or older at screening who signed written Informed Consent
* Patients with coronary artery disease undergoing cardiac catheterization and PCI for a target lesion and also have a non-obstructive lesion (30-50% stenosis) identified by angiography
* Patients who are not candidates for PCI or CABG currently or over the next 12 months, in the opinion of the investigator
* Patients treated with statins for at least 4 weeks with LDL-C level ≥ 80 mg/dL for low- or moderate -intensity statin use and ≥ 60 mg/dL for high-dose statin. Patients with history of statin intolerance and LDL-C ≥ 100 mg/dL.
* Angiographic criteria: 30-50% reduction of lumen diameter in addition to the target lesion accessible by the OCT catheter. The target segment should not have a history of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), and may not be a bypass graft.
* OCT criteria: target segment should have a lipid-rich plaque with lipid arc \>90° and fibrous cap thickness ≤120 µm.
* Women of childbearing potential must agree to be on an acceptable method of birth control/contraceptive
Exclusion criteria:
* Patients who have acute myocardial infarction (Q wave or non-Q wave with CK-MB \> 5 times above the upper normal (31.5 ng/ml) within 72 hours)
* Patients who are in cardiogenic shock
* Patients with left main disease, in-stent restenotic lesions or patients requiring coronary artery bypass graft surgery
* Patients with elevated CK-MB (\>6.3 ng/ml) or Tnl (\>0.5 ng/ml)
* Patients with platelet count \< 100,000 cell/mm3
* Patients who have co-morbidity which reduces life expectancy to one year
* Patients who are currently participating in another investigational drug/device study
* Patients with liver disease
* Patient with creatinine \> 2.0 mg/dL
* Pregnant women and women of childbearing potential who intend to have children during the duration of the trial
* Patients having undergone heart transplantation, or those that may undergo heart transplantation during the study period
* Patients with active autoimmune disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04710368
Study Brief:
Protocol Section:
NCT04710368