Coronary Artery DiseaseNCT00777842
Evaluation of the GTX™ 5126 DES Coronary Stent System in the Treatment of Patients With a Lesion in the Coronary Artery
A study testing GTX™ Drug Eluting Coronary Stent System in people with Coronary Artery Disease, run by Cook Group Incorporated at 1 site in Germany.
Trial summary
The GTX™ Drug Eluting Coronary Stent System is intended for the treatment of patients with a lesion in the coronary artery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- GTX™ Drug Eluting Coronary Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2008to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Coronary Artery Disease
- Being tested
- GTX™ Drug Eluting Coronary Stent System
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTX™ Drug Eluting Coronary Stent SystemDevice
Drug eluting stent
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Device Receives: Device: GTX™ Drug Eluting Coronary Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vessel Lumen Patency
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: In this feasibility study device did not perform as well as expected.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00777842
- Sponsor's protocol ID
- 08-010
- Other IDs
- 100021, CSCT
- Status last verified
- Mar 2015
- First submitted
- 20 Oct 2008
- Last updated
- 31 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silencing the c-Myc Gene Using Third Generation Antisense Restenosis Therapy
- ClinicalTrials.gov ID
- NCT00777842
- Acronym / sponsor ID
- 08-010
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In this feasibility study device did not perform as well as expected.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 22 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The GTX™ Drug Eluting Coronary Stent System is intended for the treatment of patients with a lesion in the coronary artery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: GTX™ Drug Eluting Coronary Stent SystemDevice |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GTX™ Drug Eluting Coronary Stent SystemDrug eluting stent | Device | 1 |
Primary outcome
Vessel Lumen Patency
Time frame: 6 months
Results and safety
The study was stopped early (reason given: In this feasibility study device did not perform as well as expected.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GTX™ Drug Eluting Coronary Stent System in people with Coronary Artery Disease, run by Cook Group Incorporated at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: In this feasibility study device did not perform as well as expected.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vessel Lumen Patency (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2015.