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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

NCT ID: NCT00777842

Last Updated: 2015-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-12-31

Brief Summary

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

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Device

Group Type EXPERIMENTAL

GTX™ Drug Eluting Coronary Stent System

Intervention Type DEVICE

Drug eluting stent

Interventions

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GTX™ Drug Eluting Coronary Stent System

Drug eluting stent

Intervention Type DEVICE

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Essen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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100021, CSCT

Identifier Type: -

Identifier Source: secondary_id

08-010

Identifier Type: -

Identifier Source: org_study_id