Evaluation of the GTX™ 5126 DES Coronary Stent System in the Treatment of Patients With a Lesion in the Coronary Artery
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00777842
(In this feasibility study device did not perform as well as expected.)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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.