Evaluation of the GTX™ 5126 DES Coronary Stent System in the Treatment of Patients With a Lesion in the Coronary Artery
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ClinicalTrials.gov Identifier: NCT00777842
Recruitment Status :
(In this feasibility study device did not perform as well as expected.)
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Key Inclusion Criteria:
Patient has discrete de novo lesion of a coronary artery with symptomatic ischemic heart disease
Planned treatment of one lesion with a single stent
Denovo type A, B1 lesions with a Reference diameter between 3.0 and 3.5mm and a lesion length between 5 and 16mm
Key Exclusion Criteria:
Diabetic (HbA1C >6.0)
Platelet count < 100000 cells/mm3 or > 700000 cells/mm3; WBC < 3000 cells/mm3; or a hemoglobin < 10 g/dl
Renal dysfunction with creatinine > 2.0 mg/dl
Patient has a known pre-dilatation ejection fraction (EF) less than forty five (<45%)
Myocardial infarction (MI) less than 3 months prior to intervention
Patient has type B2, C lesion
Reference artery diameter <3.0 or >3.6 mm
Target lesion length < 5mm and >16 mm
Other stenosis >50% in target vessel
Known hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine, or cobalt chromium, or a sensitivity to contrast agent that, in the opinion of the investigator, cannot be adequately premedicated.