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 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT00606333
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older
* Eligible for percutaneous coronary intervention and coronary artery bypass graft surgery.
* Diagnosis of stable or unstable angina or silent ischemia
* Left ventricular ejection fraction \>30%
* The subject requires treatment of a single de novo lesion in a native coronary artery.
* Lesion to be treated is less than or equal to 28 mm in length in a vessel that is 2.5-3.5mm diameter.
* The target lesion diameter stenosis is \>50% and \<100% by visual estimate.
* The target lesion is a minimum of 10 mm distance from any previously treated segment of the target vessel.
* The subject understands the study requirements, is willing to comply with all study procedures and has provided written informed consent.
Exclusion Criteria:
* The subject has undergone coronary revascularization to any vessel within 30 days.
* The subject has undergone target vessel revascularization within 6 months.
* Treatment of more than one qualifying lesion is required at the time of enrollment, or is planned within 30 days following enrollment.
* The subject has known sensitivity to sirolimus, paclitaxel, the polymeric matrices, stainless steel or cobalt chromium.
* There is planned treatment of the target lesion with any device other than the pre-dilatation balloon angioplasty catheter.
* The subject had a myocardial infarction within 72 hours, or presents with CK elevation \> 2 times upper limit normal associated with elevated CK-MB.
* The subject is in cardiogenic shock.
* The subject had a cerebrovascular accident within the past 6 months.
* The subject has acute or chronic renal dysfunction (defined as creatinine \>2.0 mg/dl).
* The subject has a contraindication to aspirin or clopidogrel.
* The subject has thrombocytopenia (platelet count \< 100,000/mm3.
* The subject has had active gastrointestinal bleeding within the past 3 months.
* The subject has a known bleeding or hypercoagulable disorder.
* The subject has had prior anaphylactoid reaction to contrast agents or has contrast sensitivity that cannot be controlled with pre-medication.
* The subject is currently taking immunosuppressant therapy.
* The subject is currently, or has been treated wtih either Rapamune or paclitaxel within 12 months of the procedure.
* The subject is a female with a positive pregnancy test or is lactating.
* The subject has an active infection.
* The subject has co-morbidities that could interfere wtih completion of study procedures, or life expectancy less than 24 months.
* The subject is participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study.
Angiographic Exclusion Criteria
* Left main disease \>50% diameter stenosis.
* The target lesion is ostial.
* The target lesion or target vessel are severely calcified.
* The target lesion involves a bifurcation with diseased branch vessel greater than or equal to 2.0 mm that would require intervention or protection.
* The target lesion has TIMI o or TIMI I flow.
* Angiographic evidence of thrombus.
* The target vessel has had prior stent placement.
* The patient has had prior coronary brachytherapy.
* There is angiographic restenosis of any previously treated segment of the target vessel, or atherosclerotic area wtih \>50% diameter stenosis outside of the target lesion.
* The subject has undergone prior CABG.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00606333
Study Brief:
Protocol Section:
NCT00606333