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

Cook Group

Status: Terminated

Conditions: Coronary Artery Disease

Treatments: Device: GTX™ Drug Eluting Coronary Stent System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00777842

08-010

100021, CSCT

Details and patient eligibility

About

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

Enrollment: 19 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

19 participants in 1 patient group

1

Experimental group

Description:

Device

Treatment:

Device: GTX™ Drug Eluting Coronary Stent System