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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

This study has been terminated.
(In this feasibility study device did not perform as well as expected.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00777842
First Posted: October 22, 2008
Last Update Posted: December 31, 2015
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.
Information provided by (Responsible Party):
Cook Group Incorporated
  Purpose
The GTX™ Drug Eluting Coronary Stent System is intended for the treatment of patients with a lesion in the coronary artery.

Condition Intervention
Coronary Artery Disease Device: GTX™ Drug Eluting Coronary Stent System

Study Type: Interventional
Study Design: 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

Further study details as provided by Cook Group Incorporated:

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

Enrollment: 19
Study Start Date: November 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Device
Device: GTX™ Drug Eluting Coronary Stent System
Drug eluting stent

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
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
Germany
Essen, Germany
Sponsors and Collaborators
Cook Group Incorporated
  More Information

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT00777842     History of Changes
Other Study ID Numbers: 08-010
100021, CSCT
First Submitted: October 20, 2008
First Posted: October 22, 2008
Last Update Posted: December 31, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases