Evaluation of Two Reduced Sirolimus Doses in Treatment of de Novo Coronary Artery Lesions (REDOX)
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)
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 coronary-artery-disease
Started Sep 2002
Longer than P75 for phase_1 coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 4, 2005
CompletedFirst Posted
Study publicly available on registry
October 6, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedApril 24, 2008
April 1, 2008
5.3 years
October 4, 2005
April 17, 2008
Conditions
Outcome Measures
Primary Outcomes (4)
Late loss measured by quantitative coronary angiography at four-months and twelve-months post-procedure.
four-months and twelve-months post-procedure
NIH volume as measured by intravascular ultrasound (IVUS) at four-months and twelve-months post-procedure.
four-months and twelve-months post-procedure
Volumetric plaque burden as measured by IVUS at four-months and twelve months post-procedure.
four-months and twelve months post-procedure
Four and twelve month target vessel failure (TVF).
Four and twelve month
Interventions
Eligibility Criteria
You may qualify if:
- 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);
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cordis US Corp.lead
Study Sites (1)
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil
Related Publications (1)
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.
PMID: 17621671BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J. E. Sousa, MD
Instituto Dante Pazzanese de Cardiologia
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 4, 2005
First Posted
October 6, 2005
Study Start
September 1, 2002
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
April 24, 2008
Record last verified: 2008-04