Study Stopped
In this feasibility study device did not perform as well as expected.
Evaluation of the GTX™ 5126 DES Coronary Stent System in the Treatment of Patients With a Lesion in the Coronary Artery
Silencing the c-Myc Gene Using Third Generation Antisense Restenosis Therapy
2 other identifiers
interventional
19
1 country
1
Brief Summary
The GTX™ Drug Eluting Coronary Stent System is intended for the treatment of patients with a lesion in the coronary artery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable coronary-artery-disease
Started Nov 2008
Shorter than P25 for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2008
CompletedFirst Posted
Study publicly available on registry
October 22, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedDecember 31, 2015
March 1, 2015
1.1 years
October 20, 2008
December 29, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Vessel Lumen Patency
6 months
Study Arms (1)
1
EXPERIMENTALDevice
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Essen, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2008
First Posted
October 22, 2008
Study Start
November 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
December 31, 2015
Record last verified: 2015-03