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 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT01925027
Eligibility Criteria:
Inclusion Criteria:
* 18 to 85 years.
* Evidence of myocardial ischemia without raised troponin (e.g. stable or unstable angina, silent ischemia demonstrated by positive territorial functional study).
* The patient has a planned intervention of up to two de novo lesions in different epicardial vessels
* Lesion(s) must have a visually estimated diameter stenosis of ≥50% and \<100%.
* Lesion length must be \<18mm
* RVD must be between 2.5-4.0 mm
* Written informed consent.
* The patient and the patient's physician agree to the follow-up visits including angiographic follow-up and OCT assessment at 3 months.
Exclusion Criteria:
* Evidence of ongoing acute myocardial infarction in ECG prior to procedure.
* LVEF \<30%.
* Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3, a WBC of \<3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis).
* Known renal insufficiency (e.g., eGFR \<60 ml/kg/m2 or serum creatinine level of \>2.5 mg/dL, or subject on dialysis).
* History of bleeding diathesis or coagulopathy.
* The patient is a recipient of a heart transplant.
* Known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel prasugrel, ticagrelor and ticlopidine), sirolimus or stainless steel.
* Other medical illness (e.g. cancer, stroke with neurological deficiency) or known history of substance abuse (alcohol, cocaine, heroin etc.) as per physician judgment that may cause non-compliance with the protocol or confound the data interpretation or is associated with a limited life expectancy
* Participating in other drugs or medical devices clinical trials, prior to reaching the primary endpoint.
* Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01925027
Study Brief:
Protocol Section:
NCT01925027