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 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT00297804
Eligibility Criteria:
Inclusion Criteria:
* General Inclusion Criteria
1. Patient \>or= 18 years old
2. Eligible for percutaneous coronary intervention
3. Documented stable angina pectoris or unstable angina pectoris with documented ischemia or documented silent ischemia
4. Acceptable candidate for CABG
5. Patient (or legal guardian) understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
6. Willing to comply with all specified follow-up evaluations
* Angiographic Inclusion Criteria
1. Target lesion located within a single native coronary vessel
2. Target lesion randomized to treatment with the study device may be composed of multiple lesions but must be completely coverable by up to 2 study stents (maximum allowable stent length of 48 mm).
3. Cumulative target lesion length is \>or= 18 mm and \<or= 40 mm (visual estimate)
4. RVD of \>or= 2.5 mm to \<or= 3.75 mm (visual estimate)
5. Target lesion diameter stenosis \>or=50% (visual estimate)
6. Target lesion is de novo
Exclusion Criteria:
* General Exclusion Criteria:
1. Known sensitivity to paclitaxel
2. Any previous or planned treatment with any anti-restenotic drug-coated or drug-eluting coronary stent (Note: previous or planned treatment with heparin or phosphorylcholine coated stents is acceptable, as long as the procedure with the stent meets the protocol defined criteria for staged procedures)
3. Previous or planned treatment with intravascular brachytherapy in the target vessel
4. MI within 72 hours prior to the study procedure and/or CK-MB \>2x the local laboratory's upper limits of normal (refers to a measured value on the day of the study procedure)
5. Left ventricular ejection fraction \<25%
6. Cerebrovascular Accident within the past 6 months
7. Acute or chronic renal dysfunction (creatinine \>1.7 mg/dl or \>150 µmol/L)
8. Contraindication to ASA, or to both clopidogrel and ticlopidine
9. Leukopenia (leukocyte count \<3.5 x 109/liter)
10. Thrombocytopenia (platelet count \<100,000/mm3)
11. Active peptic ulcer or active gastrointestinal bleeding
12. Known allergy to stainless steel
13. Any prior true anaphylactic reaction to contrast agents
14. Known anaphylactoid or other non-anaphylactic allergic reactions to contrast agents that cannot be adequately pre-medicated prior to the study procedure
15. Patient is currently taking colchicine
16. Patient is currently, or has been treated with paclitaxel within 12 months of the study procedure
17. Female of childbearing potential with a positive pregnancy test within 7 days before the study procedure, or lactating, or intends to become pregnant during the study
18. Life expectancy of less than 24 months due to other medical conditions
19. Co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
20. Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study
* Angiographic Exclusion Criteria
1. Left main coronary artery disease (stenosis \>50%), whether protected or unprotected
2. Target lesion is ostial in location (within 3.0 mm of vessel origin)
3. Target lesion(s) and/or target vessel proximal to the target lesion(s) is moderately or severely calcified by visual estimation
4. Target lesion is located within or distal to a \>60°bend in the vessel
5. Target lesion involves a bifurcation with a diseased (\>50% stenotic) branch vessel \>2.0 mm in diameter
6. Target lesion is totally occluded Thrombolysis in MI (TIMI flow \<or= 1)
7. Angiographic presence of probable or definite thrombus
8. Target vessel will be pre-treated with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon or transluminal extraction catheter immediately prior to stent placement
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00297804
Study Brief:
Protocol Section:
NCT00297804