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:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-26 @ 4:04 PM
NCT ID:
NCT01242306
Eligibility Criteria:
Inclusion Criteria:
* stable angina pectoris
* at least two significant angiographic stenoses in different native coronary vessels or in the same vessel but two different ramifications with similar diameter
* non-surgical patients
Exclusion Criteria:
* acute coronary syndromes
* myocardial infarction within 3 months from event
* clinical or angiographic coronary vasospasm
* coronary angiographic findings of a fresh thrombus in the initial angiography (filling defect proximal to or involving the stenosis)
* coronary anatomy unsuitable for for intracoronary acetylcholine testing (left main coronary artery disease \>30%, surgical three vessel disease or other anatomical considerations that make it unsafe to perform intracoronary studies)
* progression of lesions or development of de novo lesions in nontarget lesions or vessels on follow-up angiography
* patients with a vessel diameter \< 2,50 mm and length lesions \<10 and \>30 mm.
* patients with vessel diameter difference (SES vs BMS) \>0,5mm and length difference of the stenosis \>50%
* lesions treated with balloon injury \<10 mm or \>50 mm in length
* severe left ventricular (LV) systolic dysfunction
* bifurcation/ostial
* presence of an unhealed dissection identified by intravascular ultrasound (IVUS) performed at the end of the study.
* angiographic restenosis in follow-up angiography
* patients with severe risk factors for endothelial dysfunction: severe renal failure, life expectancy less than 1 year, uncontrolled diabetes, uncontrolled hypertension (systolic blood pressure \>180mmHg), currently smoking, uncontrolled hypercholesterolemia (total cholesterol \>240mg/dl)
* any contraindication/nontolerance to the use of aspirin, heparin and/or clopidogrel
* lack of consent to participate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01242306
Study Brief:
Protocol Section:
NCT01242306