Back to resultsEvaluation of Two Reduced Sirolimus Doses in Treatment of de Novo Coronary Artery Lesions (REDOX)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Bx VELOCITY Stent containing 45% and 70% of Sirolimus dose
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria: 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); Exclusion Criteria: 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;
Sites / Locations
- Instituto Dante Pazzanese de Cardiologia
Outcomes
Primary Outcome Measures
Late loss measured by quantitative coronary angiography at four-months and twelve-months post-procedure.
NIH volume as measured by intravascular ultrasound (IVUS) at four-months and twelve-months post-procedure.
Volumetric plaque burden as measured by IVUS at four-months and twelve months post-procedure.
Four and twelve month target vessel failure (TVF).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00233766
Brief Title
Evaluation of Two Reduced Sirolimus Doses in Treatment of de Novo Coronary Artery Lesions (REDOX)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cordis Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Bx VELOCITY Stent containing 45% and 70% of Sirolimus dose
Primary Outcome Measure Information:
Title
Late loss measured by quantitative coronary angiography at four-months and twelve-months post-procedure.
Time Frame
four-months and twelve-months post-procedure
Title
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
Title
Volumetric plaque burden as measured by IVUS at four-months and twelve months post-procedure.
Time Frame
four-months and twelve months post-procedure
Title
Four and twelve month target vessel failure (TVF).
Time Frame
Four and twelve month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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);
Exclusion Criteria:
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. E. Sousa, MD
Organizational Affiliation
Instituto Dante Pazzanese de Cardiologia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Dante Pazzanese de Cardiologia
City
Sao Paolo
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
17621671
Citation
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.
Results Reference
background
Learn more about this trial
Evaluation of Two Reduced Sirolimus Doses in Treatment of de Novo Coronary Artery Lesions (REDOX)
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