Evaluation of the GTX™ 5126 DES Coronary Stent System in the Treatment of Patients With a Lesion in the Coronary Artery

Coronary Artery Disease Clinical Trial

Official title:

Silencing the c-Myc Gene Using Third Generation Antisense Restenosis Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00777842
• Other study ID #: 08-010
• Secondary ID: 100021, CSCT
• Status: Terminated
• Phase: N/A
• First received: October 20, 2008
• Last updated: December 29, 2015
• Start date: November 2008
• Est. completion date: December 2009

Study information

• Verified date: March 2015
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: German Institute of Medical Documentation and Information
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• GTX™ Drug Eluting Coronary Stent System
Drug eluting stent

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cook

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vessel Lumen Patency		6 months	Yes