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 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT01255956
Eligibility Criteria:
Inclusion Criteria:
* at least 18 years of age
* symptomatic restenosis in bare metal stent implanted in native coronary artery
* angina pectoris
* ischemia evidenced by non-invasive diagnostic tests
* angiographically evidenced in-stent restenosis \> 50% assessed by quantitative coronary angiography (QCA)
* vessel diameter \> 2,5 mm
Clinical exclusion criteria:
* myocardial infarction within less than past 72 hours
* heart failure with left ventricular ejection fraction (LVEF) \< 30%
* chronic renal failure with significant impairment of glomerular filtration (creatinine \> 2 mg/dl)
* hypersensitivity or contraindication to acetylsalicylic acid, clopidogrel, heparin, abciximab, rapamycin, paclitaxel
* hypersensitivity to contrast
* other diseases that may cause significant deterioration in long-term prognosis
* acute or chronic inflammatory diseases
* patients who are unwilling to consent for participation in the study
Angiographic exclusion criteria:
* significant stenosis in left main coronary artery (LM)
* multivessel disease qualifying for coronary artery bypass grafting (CABG)
* anatomical localization and morphology that preclude optimal percutaneous intervention intervention's (PCI) result or intravascular ultrasound (IVUS) or optical coherence tomography performance
* vessel diameter \< 2,5 mm
* restenotic lesion length \> 30 mm
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01255956
Study Brief:
Protocol Section:
NCT01255956