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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
Cook Group Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 20, 2008
Last Updated
December 29, 2015
Sponsor
Cook Group Incorporated
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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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