- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00777842
Evaluation of the GTX™ 5126 DES Coronary Stent System in the Treatment of Patients With a Lesion in the Coronary Artery
December 29, 2015 updated by: Cook Group Incorporated
Silencing the c-Myc Gene Using Third Generation Antisense Restenosis Therapy
The GTX™ Drug Eluting Coronary Stent System is intended for the treatment of patients with a lesion in the coronary artery.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Essen, Germany
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Device
|
Drug eluting stent
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Vessel Lumen Patency
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
October 20, 2008
First Submitted That Met QC Criteria
October 21, 2008
First Posted (Estimate)
October 22, 2008
Study Record Updates
Last Update Posted (Estimate)
December 31, 2015
Last Update Submitted That Met QC Criteria
December 29, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-010
- 100021, CSCT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Artery Disease
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Elixir Medical CorporationIstituto Clinico HumanitasActive, not recruitingCoronary Artery Disease | Chronic Total Occlusion of Coronary Artery | Multi Vessel Coronary Artery Disease | Bifurcation of Coronary Artery | Long Lesions Coronary Artery DiseaseItaly
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Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
-
Peking Union Medical College HospitalNot yet recruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
Peking Union Medical College HospitalRecruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
IGLESIAS Juan FernandoUniversity of BernNot yet recruiting
-
Barts & The London NHS TrustImperial College London; Brunel UniversityNot yet recruitingCORONARY ARTERY DISEASE
-
National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
-
Fundación EPICRecruitingCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Left Main Coronary Artery Disease | Coronary Artery StenosisSpain
-
China National Center for Cardiovascular DiseasesRecruitingLeft Main Coronary Artery DiseaseChina
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Chronic Total Occlusion of Coronary Artery | Coronary Restenosis | Coronary Artery Stenosis | Coronary Artery RestenosisBelgium
Clinical Trials on GTX™ Drug Eluting Coronary Stent System
-
ReFlow Medical, Inc.Not yet recruiting
-
Atrium Medical CorporationTerminatedCoronary Artery DiseaseNew Zealand
-
Cook Group IncorporatedCompleted
-
Cook Group IncorporatedCompleted
-
National Taiwan University HospitalUnknownImaging and Interventional Study for Erectile Dysfunction and Lower Urinary Tract Symptoms (PERFECT)Lower Urinary Tract Symptoms | Peripheral Arterial Disease | Erectile DysfunctionTaiwan
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Medtronic VascularCompletedCoronary Artery DiseaseUnited States, Belgium, France, Slovakia
-
Medtronic VascularCompletedCardiovascular Diseases | Coronary Artery Disease | Arteriosclerosis | Ischemic Heart DiseaseChina
-
Medtronic VascularMedtronic Japan Co., Ltd.CompletedMyocardial Ischemia | Cardiovascular Diseases | Coronary Artery Disease | Arterial Occlusive DiseasesJapan
-
Biotronik AGCompletedCoronary Artery DiseaseRomania
-
Medtronic VascularCompletedIschemia | Myocardial Ischemia | Heart Diseases | Vascular Diseases | Coronary Artery Disease | Coronary Disease | Arteriosclerosis | Arterial Occlusive Diseases | Coronary ArteriosclerosisFrance