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 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
NCT ID:
NCT00235066
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS 1, 2, 3, 4) OR unstable angina pectoris (Braunwald Classification B\&C 1-2) OR patients with documented silent ischemia;
2. Single treatment of de novo lesion in a small vessel (2.25 - 2.75 mm) in a major coronary artery in patients with single or multivessel disease. Patients with multiple lesions can be included if the other lesions are successfully treated prior to the treatment of the intended lesion in the small vessel.
3. Target vessel diameter \>=2.25 and \<=2.75mm (by visual estimation);
4. Target lesion length \>=15 and \<=30 mm.
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 24 hours or the CK and CK-MB remains above normal at the time of the treatment;
2. Has unstable angina classified as Braunwald A (1, 2, 3) or B \& C 3;
3. Unprotected left main coronary disease with \>=50% stenosis;
4. Significant (\>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede inflow or runoff;
5. Have an ostial target lesion;
6. Lesion \< 2.25 or \> 2.75 mm in diameter;
7. Totally occluded vessel (TIMI 0 level);
8. Documented left ventricular ejection fraction £30%;
9. Intention to treat the target lesion by direct stenting procedure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00235066
Study Brief:
Protocol Section:
NCT00235066