Coronary Artery DiseasePhase 1/2NCT00233766
Evaluation of Two Reduced Sirolimus Doses in Treatment of de Novo Coronary Artery Lesions (REDOX)
A Phase 1/2 study testing Bx VELOCITY Stent containing 45% and 70% of Sirolimus dose in people with Coronary Artery Disease, run by Cordis US Corp. at 1 site in Brazil.
Trial summary
The objective of this study is to assess the performance and safety of two reduced sirolimus doses on the Bx VELOCITY Balloon-Expandable stent, mounted on the Raptorâ rapid exchange (RX) Stent Delivery System (SDS) in patients with de novo native coronary artery lesions. 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?
- Bx VELOCITY Stent containing 45% and 70% of Sirolimus dose
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2002to Dec 2007
- Phase
- Phase 1/2
- 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
- Male or non-pregnant female patient minimum 18 years of age
- No significant (>50%) untreated stenoses proximal or distal to the target lesion that will not be treated during the procedure and may require revascularization or impede runoff;
- Target lesion is 18mm in length (visual estimate);
- Target lesion is 3.0mm and 3.5mm in diameter (visual estimate);
- Target lesion stenosis is >50% and <100% (visual estimate);
Who cannot join
- A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal;
- Ejection fraction 30%;
- Stent placement of target lesion covers a side branch >2.0mm in diameter;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of Two Reduced Sirolimus Doses on the BX VELOCITY Balloon-Expandable Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions(REDOX)
The objective of this study is to assess the performance and safety of two reduced sirolimus doses on the Bx VELOCITY Balloon-Expandable stent, mounted on the Raptorâ rapid exchange (RX) Stent Delivery System (SDS) in patients with de novo native coronary artery lesions.
- Conditions
- Coronary Artery Disease
- Being tested
- Bx VELOCITY Stent containing 45% and 70% of Sirolimus dose
- 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.
Bx VELOCITY Stent containing 45% and 70% of Sirolimus doseDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Late loss measured by quantitative coronary angiography at four-months and twelve-months post-procedure.
Measured: four-months and twelve-months post-procedure
NIH volume as measured by intravascular ultrasound (IVUS) at four-months and twelve-months post-procedure.
Measured: four-months and twelve-months post-procedure
Volumetric plaque burden as measured by IVUS at four-months and twelve months post-procedure.
Measured: four-months and twelve months post-procedure
Four and twelve month target vessel failure (TVF).
Measured: Four and twelve month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2005 (estimated)
- Study startSep 2002
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- J. E. Sousa, MD, Principal investigator, Instituto Dante Pazzanese de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00233766
- Sponsor's protocol ID
- P02-6314
- Status last verified
- Apr 2008
- First submitted
- 4 Oct 2005
- Last updated
- 24 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Nakamura M, Abizaid A, Hirohata A, Honda Y, Sousa JE, Fitzgerald PJ. Efficacy of reduced-dose sirolimus-eluting stents in the human coronary artery: serial IVUS analysis of neointimal hyperplasia and luminal dimension. Catheter Cardiovasc Interv. 2007 Dec 1;70(7):946-51. doi: 10.1002/ccd.21272.
PubMed 17621671
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Two Reduced Sirolimus Doses on the BX VELOCITY Balloon-Expandable Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions(REDOX)
- ClinicalTrials.gov ID
- NCT00233766
- Acronym / sponsor ID
- P02-6314
- Conditions
- Coronary Artery Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Study start
- Sep 2002
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 6 Oct 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 objective of this study is to assess the performance and safety of two reduced sirolimus doses on the Bx VELOCITY Balloon-Expandable stent, mounted on the Raptorâ rapid exchange (RX) Stent Delivery System (SDS) in patients with de novo native coronary artery lesions.
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 (5 listed)
- Male or non-pregnant female patient minimum 18 years of age
- No significant (>50%) untreated stenoses proximal or distal to the target lesion that will not be treated during the procedure and may require revascularization or impede runoff;
- Target lesion is 18mm in length (visual estimate);
- Target lesion is 3.0mm and 3.5mm in diameter (visual estimate);
- Target lesion stenosis is >50% and <100% (visual estimate);
Key exclusion criteria (3 listed)
- A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal;
- Ejection fraction 30%;
- Stent placement of target lesion covers a side branch >2.0mm in diameter;
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 |
|---|---|---|
| Bx VELOCITY Stent containing 45% and 70% of Sirolimus dose | Device | – |
Primary outcome
Late loss measured by quantitative coronary angiography at four-months and twelve-months post-procedure.
Time frame: four-months and twelve-months post-procedure
NIH volume as measured by intravascular ultrasound (IVUS) at four-months and twelve-months post-procedure.
Time frame: four-months and twelve-months post-procedure
Volumetric plaque burden as measured by IVUS at four-months and twelve months post-procedure.
Time frame: four-months and twelve months post-procedure
Four and twelve month target vessel failure (TVF).
Time frame: Four and twelve month
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 24 Apr 2008.
- Background: PubMed 17621671Nakamura M, Abizaid A, Hirohata A, Honda Y, Sousa JE, Fitzgerald PJ. Efficacy of reduced-dose sirolimus-eluting stents in the human coronary artery: serial IVUS analysis of neointimal hyperplasia and luminal dimension. Catheter Cardiovasc Interv. 2007 Dec 1;70(7):946-51. doi: 10.1002/ccd.21272.
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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.
J. E. Sousa, MD principal investigator
Instituto Dante Pazzanese de Cardiologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bx VELOCITY Stent containing 45% and 70% of Sirolimus dose in people with Coronary Artery Disease, run by Cordis US Corp. at 1 site in Brazil.
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 5 inclusion and 3 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 24 Apr 2008. 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 Brazil. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Late loss measured by quantitative coronary angiography at four-months and twelve-months post-procedure. (time frame: four-months and twelve-months post-procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00233766, which also lists 1 linked publication.
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 24 Apr 2008.