Status:
TERMINATED
Evaluation of the GTX™ 5126 DES Coronary Stent System in the Treatment of Patients With a Lesion in the Coronary Artery
Lead Sponsor:
Cook Group Incorporated
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The GTX™ Drug Eluting Coronary Stent System is intended for the treatment of patients with a lesion in the coronary artery.
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00777842
Start Date
November 1 2008
End Date
December 1 2009
Last Update
December 31 2015
Active Locations (1)
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1
Essen, Germany