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 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT00232804
Eligibility Criteria:
Inclusion Criteria:
1. NIDDM treated with oral antidiabetics for at least 3 months, or IDDM treated for at least 3 months with documented HbA1C;
2. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B I-II) OR patients with documented silent ischemia;
3. Target lesion stenosis is \>50% (visual estimate);
4. Target vessel diameter, between 2.5 and 3.0 mm
5. Target lesion length minimum 15 mm and maximum 30mm
Exclusion Criteria:
1. CK and CK-MB enzymes above normal or elevated troponin level (as determined by site criteria) at the time of treatment;
2. Has unstable angina classified as Braunwald III B and A or C I-II-III, or is having a peri-infarction;
3. Unprotected left main coronary disease with \>=50% stenosis;
4. Significant (\>50%) stenosis proximal or distal to the target lesion that might impede inflow or runoff and can not be revascularized before or during the index procedure;
5. Have an ostial target lesion;
6. Documented left ventricular ejection fraction \<=30%;
7. In-Stent restenosis;
8. Chronic total occlusion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00232804
Study Brief:
Protocol Section:
NCT00232804