Coronary Artery DiseaseELUTES IIINCT00225693
V-Flex Plus PTX Drug Eluting Coronary Stent
A study testing drug eluting coronary stent in people with Coronary Artery Disease, run by Cook Group Incorporated at 1 site in United States.
Trial summary
The study is intended to collect data to evaluate effectiveness and safety of drug eluting stent devices in a dose ranging assessment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- drug eluting coronary stent
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Jul 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be eligible to undergo planned treatment of a single de novo lesion in a native coronary artery.
- Patient must be an acceptable candidate for coronary artery bypass surgery
- Patient or legal guardian must have given informed consent
- Patient agrees to return at one month for an office visit to assess cardiovascular status and at 6 months for an office visit to assess cardiovascular status, an IVUS examination and a diagnostic angiogram.
Who cannot join
- Patient must be less than 18 years old
- Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- Patient is simultaneously participating in another investigative interventional cardiovascular device or drug study.
- Patient has known hypersensitivity or contraindication to aspirin, clopidogrel, or stainless steel, or a sensitivity to contrast dye.
- Women of child bearing potential.
- Patient has other medical condition that any cause non-compliance with the protocol, confound the results or is associated with limited life expectancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ELUTES III - V-Flex Plus PTX Drug Eluting Coronary Stent
The study is intended to collect data to evaluate effectiveness and safety of drug eluting stent devices in a dose ranging assessment.
- Conditions
- Coronary Artery Disease
- Being tested
- drug eluting coronary stent
- Keywords
- coronary artery, restenosis, patency, drug eluting, stent
- 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.
drug eluting coronary stentDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation by IVUS of % diameter stenosis at follow up.
Secondary outcomes (2)
Major adverse events
Target lesion revascularization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startOct 2003
- Study completionJul 2005
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joseph Dens, MD, Principal investigator, UZ Gasthuisberg Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225693
- Sponsor's protocol ID
- 578
- Acronym
- ELUTES III
- Status last verified
- Jan 2012
- First submitted
- 12 Sep 2005
- Last updated
- 1 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ELUTES III - V-Flex Plus PTX Drug Eluting Coronary Stent
- ClinicalTrials.gov ID
- NCT00225693
- Acronym / sponsor ID
- ELUTES III / 578
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery, restenosis, patency, drug eluting, stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Study completion
- Jul 2005
- First posted
- 26 Sep 2005 (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 study is intended to collect data to evaluate effectiveness and safety of drug eluting stent devices in a dose ranging assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient must be eligible to undergo planned treatment of a single de novo lesion in a native coronary artery.
- Patient must be an acceptable candidate for coronary artery bypass surgery
- Patient or legal guardian must have given informed consent
- Patient agrees to return at one month for an office visit to assess cardiovascular status and at 6 months for an office visit to assess cardiovascular status, an IVUS examination and a diagnostic angiogram.
Key exclusion criteria (6 listed)
- Patient must be less than 18 years old
- Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- Patient is simultaneously participating in another investigative interventional cardiovascular device or drug study.
- Patient has known hypersensitivity or contraindication to aspirin, clopidogrel, or stainless steel, or a sensitivity to contrast dye.
- Women of child bearing potential.
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 |
|---|---|---|
| drug eluting coronary stent | Device | – |
Primary outcome
Evaluation by IVUS of % diameter stenosis at follow up.
2 secondary outcomes
Major adverse events
Target lesion revascularization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2012.
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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.
Joseph Dens, MD principal investigator
UZ Gasthuisberg Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing drug eluting coronary stent in people with Coronary Artery Disease, run by Cook Group Incorporated at 1 site in United States.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 1 Feb 2012. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation by IVUS of % diameter stenosis at follow up.. 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 1 Feb 2012.