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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated

Study Description
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Brief Summary:
The GTX™ Drug Eluting Coronary Stent System is intended for the treatment of patients with a lesion in the coronary artery.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: GTX™ Drug Eluting Coronary Stent System Not Applicable

Study Design
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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
Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Device
 Device: GTX™ Drug Eluting Coronary Stent System
Drug eluting stent


Outcome Measures
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Primary Outcome Measures :
  1. Vessel Lumen Patency [ Time Frame: 6 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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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
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Germany
Essen, Germany
Sponsors and Collaborators
Cook Group Incorporated
More Information
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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
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases