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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.)
Information provided by (Responsible Party):
Cook Identifier:
First received: October 20, 2008
Last updated: December 29, 2015
Last verified: March 2015
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: 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:

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: GTX™ Drug Eluting Coronary Stent System
Drug eluting stent


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00777842

Essen, Germany
Sponsors and Collaborators
  More Information

Responsible Party: Cook Identifier: NCT00777842     History of Changes
Other Study ID Numbers: 08-010
100021, CSCT
Study First Received: October 20, 2008
Last Updated: December 29, 2015

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases processed this record on June 23, 2017