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 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT00637104
Eligibility Criteria:
Inclusion Criteria:
Patients must meet ALL of the following criteria:
1. The patient must be \> 18 years of age;
2. Female of childbearing potential must have a negative pregnancy test within 7 days of enrollment and utilize reliable birth control for eight months after enrollment
3. 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;
4. 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;
5. Target vessel diameter at the lesion site is \>2.50mm and \<3.5mm in diameter (visual estimate);
6. Target lesion is \>10mm and \<22mm in length (visual estimate);
7. Target lesion stenosis is \>50% and \<100% (visual estimate);
8. At least TIMI II coronary flow;
9. Acceptable candidate for coronary artery bypass surgery (CABG);
10. Patient is willing to comply with the specified follow-up evaluation;
11. Patient must provide written informed consent prior to the procedure using a form that is approved by the local Ethics Committee.
12. Patient can be pre-treated with aspirin and clopidogrel or, alternatively, aspirin alone plus a loading dose of 300 mg of clopidogrel before procedure completion in case of urgent PCI
Exclusion Criteria:
Patients will be excluded if ANY of the following conditions apply:
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 and the CK and CK-MB enzymes remains above normal at the time of treatment;
2. Has unstable angina classified as Braunwald III B or C and A 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 require revascularization or impede runoff;
5. Have an ostial target lesion;
6. Have a target lesion in a venous graft;
7. Angiographic evidence of thrombus within target lesion;
8. Calcified lesion which cannot be successfully predilated;
9. Documented left ventricular ejection fraction \<=25%;
10. Totally occluded vessel (TIMI 0 level);
11. Impaired renal function (creatinine \> 3.0 mg/dl) at the time of treatment;
12. Pretreatment with devices other than balloon angioplasty;
13. Target lesion has excessive tortuousity or angulation (\> 45°) which makes it unsuitable for stent delivery and deployment;
14. Target lesion involves bifurcation including a diseased side branch \>=2 mm in diameter (either stenosis of both main vessel and major branch or stenosis of just major branch) that would require side branch stenting;
15. Prior stent within 5mm of target lesion;
16. Direct Stenting
17. Recipient of heart transplant;
18. Patient with a life expectancy less than 12 months;
19. Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix) and ticlopidine (Ticlid), heparin, cobalt, chromium, or contrast agent (that cannot be managed medically)
20. Recent (6 months) cerebrovascular accidents or intracranial hemorrhage
21. Any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study;
22. Currently participating in an investigational drug or another device study;
23. Intervention of another lesion has occurred within 6 months before the index procedure;
24. In the investigator's opinion, the lesion is not suitable for stenting.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00637104
Study Brief:
Protocol Section:
NCT00637104