Evaluation of the GTX™ 5126 DES Coronary Stent System in the Treatment of Patients With a Lesion in the Coronary Artery
Not Applicable
Terminated
- Conditions
- Coronary Artery Disease
- Interventions
- Device: GTX™ Drug Eluting Coronary Stent System
- Registration Number
- NCT00777842
- Lead Sponsor
- Cook Group Incorporated
- Brief Summary
The GTX™ Drug Eluting Coronary Stent System is intended for the treatment of patients with a lesion in the coronary artery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 19
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 GTX™ Drug Eluting Coronary Stent System Device
- Primary Outcome Measures
Name Time Method Vessel Lumen Patency 6 months
- Secondary Outcome Measures
Name Time Method