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 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
NCT ID:
NCT01718106
Eligibility Criteria:
Inclusion Criteria:
1. De novo coronary artery stenosis in a major coronary artery branch (reference diameter 2.5-4.0 mm) with a lenght \>28mm and \<39mm
2. Symptoms or instrumental evidence of myocardial ischemia:
* Chronic stable angina \[Canadian Cardiovascular Society Classification\]
* Unstable angina with ECG changes or troponin release (Braunwald Class IB-C, IIB-C, or IIIB-C)
* Stress ECG or myocardial perfusion imaging or stress echocardiography positive for inducible myocardial ischemia
3. Written informed consent to the study
Exclusion Criteria:
1. Pregnancy or lactation
2. Acute ST elevation myocardial infarction (primary angioplasty)
3. Cardiogenic shock
4. Known allergic reactions to aspirin, clopidogrel, prasugrel, heparin, enoxaparin, bivalirudin, steel, chromium, iodiate contrast medium
5. Platelets \<75.000/mm3 or \>700.000/mm3 or white blood cells \<3.000/mm3.
6. Partecipation to other studies.
7. Active or \<3 months peptic ulcer or gastrointestinal bleeding
8. Planned major surgery non delayable .
9. Comorbidities limiting life expectancy to \<1 year.
10. Unprotected left main disease as target lesion
11. Chronic total occlusion as target lesion
12. Bifurcation with side branch \> 2.5mm as target lesion
13. Restenosis as target lesion
14. saphenous vein graft as target lesion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01718106
Study Brief:
Protocol Section:
NCT01718106