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 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT00148356
Eligibility Criteria:
Inclusion Criteria include all of the following:
* Subject is ≥ 18 years old.
* Female of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment and utilize reliable birth control for nine (9) months after enrollment.
* Subject is eligible for percutaneous coronary intervention (PCI) and has a single lesion requiring treatment.
* Subject is an acceptable candidate for CABG.
* Subject has clinical evidence of ischemic heart disease or a positive functional study.
* Subject has documented stable angina pectoris
Exclusion Criteria include all of the following:
* Evidence of an acute myocardial infarction (AMI) or CK-MB \> 2x upper limit of normal within 72 hours of the intended treatment (refer to WHO definition).
* Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®) or ticlopidine (Ticlid®), heparin, stainless steel, tantalum, contrast agent (that cannot be adequately premedicated), paclitaxel, or drugs similar to ABT-578 (i.e. tacrolimus, sirolimus, everolimus).
* A platelet count \< 100 x 109/L or \> 700 x 109/L (\< 100,000 cells/mm3 or \> 700,000 cells/mm3); a WBC \< 3,000 cells/mm3; or a hemoglobin \< 10.0 g/dl.
* Acute or chronic renal dysfunction (creatinine \> 2.0 mg/dl or \> 150 µmol/L).
* Subject has had any previous or planned brachytherapy in the target vessel.
* Target vessel has evidence of thrombus or is excessively tortuous (\> 60 degree bend) that makes it unsuitable for proper stent delivery and deployment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00148356
Study Brief:
Protocol Section:
NCT00148356