Evaluation of the GTX™ 5126 DES Coronary Stent System in the Treatment of Patients With a Lesion in the Coronary Artery
Primary Purpose
Coronary Artery Disease
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
GTX™ Drug Eluting Coronary Stent System
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Device
Outcomes
Primary Outcome Measures
Vessel Lumen Patency
Secondary Outcome Measures
Full Information
NCT ID
NCT00777842
First Posted
October 20, 2008
Last Updated
December 29, 2015
Sponsor
Cook Group Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00777842
Brief Title
Evaluation of the GTX™ 5126 DES Coronary Stent System in the Treatment of Patients With a Lesion in the Coronary Artery
Official Title
Silencing the c-Myc Gene Using Third Generation Antisense Restenosis Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
In this feasibility study device did not perform as well as expected.
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Group Incorporated
4. Oversight
5. Study Description
Brief Summary
The GTX™ Drug Eluting Coronary Stent System is intended for the treatment of patients with a lesion in the coronary artery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Device
Intervention Type
Device
Intervention Name(s)
GTX™ Drug Eluting Coronary Stent System
Intervention Description
Drug eluting stent
Primary Outcome Measure Information:
Title
Vessel Lumen Patency
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
City
Essen
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
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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