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 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT00233805
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. Single treatment of de novo lesion in a coronary artery which can be appropriately covered by a study stent of 18mm in length in patients with single or multivessel disease; patients with multiple lesions can be included only if the other lesions do not require treatment;
3. Target lesion is \>= 2.5 and \<= 3.5mm in diameter (visual estimate);
4. Target lesion is located in a native coronary artery which can be covered by one stent (single lesion);
5. Target lesion stenosis is \>50% and \<100% (TIMI I) (visual estimate).
Exclusion Criteria:
1. A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal;
2. Unprotected left main coronary disease with \>=50% stenosis;
3. Have an ostial target lesion;
4. Angiographic evidence of thrombus within target lesion;
5. Calcified lesions which cannot be successfully predilated;
6. Ejection fraction \<=30%;
7. Totally occluded vessel (TIMI 0 level);
8. Target lesion involves bifurcation including a side branch \>=2.5mm in diameter (either stenosis of both main vessel and major branch or stenosis of just major branch) that would require side branch stenting which is likely to occur if side branch is diseased and intended to be stented;
9. Planned Direct Stenting.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT00233805
Study Brief:
Protocol Section:
NCT00233805