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 :
Terminated
(In this feasibility study device did not perform as well as expected.)
First Posted : October 22, 2008
Last Update Posted : December 31, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Artery Disease | Device: GTX™ Drug Eluting Coronary Stent System | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Silencing the c-Myc Gene Using Third Generation Antisense Restenosis Therapy |
Study Start Date : | November 2008 |
Actual Primary Completion Date : | December 2009 |
Actual Study Completion Date : | December 2009 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
Device
|
Device: GTX™ Drug Eluting Coronary Stent System
Drug eluting stent |
- Vessel Lumen Patency [ Time Frame: 6 months ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777842
Germany | |
Essen, Germany |
Responsible Party: | Cook Group Incorporated |
ClinicalTrials.gov Identifier: | NCT00777842 |
Other Study ID Numbers: |
08-010 100021, CSCT |
First Posted: | October 22, 2008 Key Record Dates |
Last Update Posted: | December 31, 2015 |
Last Verified: | March 2015 |
Coronary Artery Disease Coronary Disease Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |