Coronary Artery Disease
Conditions
Brief summary
The GTX™ Drug Eluting Coronary Stent System is intended for the treatment of patients with a lesion in the coronary artery.
Interventions
DEVICEGTX™ Drug Eluting Coronary Stent System
Drug eluting stent
Sponsors
Cook Group Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vessel Lumen Patency | 6 months |
Countries
Germany
Outcome results
None listed