Text Size

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:
Information provided by:
Cook
ClinicalTrials.gov Identifier:
NCT00777842
First received: October 20, 2008
Last updated: January 13, 2011
Last verified: January 2011
History of Changes
  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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Silencing the c-Myc Gene Using Third Generation Antisense Restenosis Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cook:

Primary Outcome Measures:
  • Vessel Lumen Patency [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: November 2008
Estimated Study Completion Date: March 2010
Estimated 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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00777842

Locations
Germany
Essen, Germany
Sponsors and Collaborators
Cook
  More Information

No publications provided

Responsible Party: Devin McBlair, QS/RA Manager, Global Therapeutics, LLC
ClinicalTrials.gov Identifier: NCT00777842     History of Changes
Other Study ID Numbers: 08-010, 100021, CSCT
Study First Received: October 20, 2008
Last Updated: January 13, 2011
Health Authority: Germany: German Institute of Medical Documentation and Information

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

ClinicalTrials.gov processed this record on May 23, 2013