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 @ 3:43 PM
Ignite Modification Date:
2025-12-24 @ 3:43 PM
NCT ID:
NCT00235092
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II-III) OR patients with documented silent ischemia;
2. Treatment of up to two de novo native coronary artery lesions in a maximum of two major coronary arteries;
3. Ostial lesions;
4. Bifurcations;
5. Target vessel diameter of both lesions must be \>=2.25mm and \<=3.0mm in diameter (visual estimate);
6. One target lesion must be at least 15 mm in length and the second lesion has to be at least 10 mm in length with no upper limit on either;
7. Target lesion stenosis for both lesions is \>50% and \<100% (visual estimate).
Exclusion Criteria:
1. Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK \>2 times normal within the preceding 72 hours and the CK and CK-MB enzymes remain above normal at the time of treatment;
2. Has unstable angina classified as Braunwald A I-II-III;
3. Any of the lesions is an unprotected left main coronary disease with \>=50% stenosis;
4. Angiographic evidence of thrombus within target lesion;
5. Heavily calcified lesion and/or calcified lesion, which cannot be successfully predilated (applies to both lesions);
6. Documented left ventricular ejection fraction \<=25%;
8\. Totally occluded vessel (TIMI 0 level) (applies to both lesions);
9\. Prior stent within 10mm of target lesion (applies to both lesions).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00235092
Study Brief:
Protocol Section:
NCT00235092