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:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT00381420
Eligibility Criteria:
Inclusion Criteria:
* 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) OR patients with documented silent ischemia;
* Single treatment of de novo lesion in a major coronary artery in patients with single or multi-vessel disease; patients with multiple lesions can be included only if the other lesions do not require treatment;
* Target vessel diameter at the lesion site is \>=2.50mm and \<=3.0mm in diameter (visual estimate);
* Target lesion is \>=15mm and \<=32mm in length (visual estimate);
* Target lesion stenosis is \>50% and \<100% (visual estimate);
Exclusion Criteria:
* Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK \>2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remains above normal at the time of treatment;
* Has unstable angina classified as Braunwald III B or C and A I-II-III, or is having a peri infarction;
* Unprotected left main coronary disease with \>=50% stenosis;
* Significant (\>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
* Have an ostial target lesion;
* Angiographic evidence of thrombus within target lesion;
* Heavily calcified lesion which cannot be successfully predilated;
* Documented left ventricular ejection fraction \<=25%.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00381420
Study Brief:
Protocol Section:
NCT00381420