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

This study is currently recruiting participants.

Verified by Cook, February 2009

First Received: October 20, 2008 Last Updated: February 6, 2009 History of Changes

Sponsored by:	Cook
Information provided by:	Cook
ClinicalTrials.gov Identifier:	NCT00777842

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

MedlinePlus related topics: Coronary Artery Disease

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Single Group Assignment, 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	October 2008
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Device	Device: GTX™ Drug Eluting Coronary Stent System Drug eluting stent

Eligibility

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 fourty 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

Contacts

Contact: Devin McBlair, RAC

303-460-1515

Locations

Germany
	Recruiting
Essen, Germany
Contact: Raimund Erbel, MD Erbel@uk-essen.de

Sponsors and Collaborators

Cook

More Information

No publications provided

Responsible Party:	Global Therapeutics, LLC ( Devin McBlair, QS/RA Manager )
Study ID Numbers:	08-010, 100021
Study First Received:	October 20, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00777842 History of Changes
Health Authority:	Germany: German Institute of Medical Documentation and Information

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on March 16, 2009