Evaluation of Two Reduced Sirolimus Doses in Treatment of de Novo Coronary Artery Lesions (REDOX)

Coronary Artery Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233766
• Other study ID #: P02-6314
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 4, 2005
• Last updated: April 17, 2008
• Start date: September 2002
• Est. completion date: December 2007

Study information

• Verified date: April 2008
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or non-pregnant female patient minimum 18 years of age

2. 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;

3. Target lesion is 18mm in length (visual estimate);

4. Target lesion is 3.0mm and 3.5mm in diameter (visual estimate);

5. Target lesion stenosis is >50% and <100% (visual estimate);

Exclusion Criteria:

1. 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;

2. Ejection fraction 30%;

3. Stent placement of target lesion covers a side branch >2.0mm in diameter;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Bx VELOCITY Stent containing 45% and 70% of Sirolimus dose

Locations

Country	Name	City	State
Brazil	Instituto Dante Pazzanese de Cardiologia	Sao Paolo

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Country where clinical trial is conducted

Brazil, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late loss measured by quantitative coronary angiography at four-months and twelve-months post-procedure.		four-months and twelve-months post-procedure
Primary	NIH volume as measured by intravascular ultrasound (IVUS) at four-months and twelve-months post-procedure.		four-months and twelve-months post-procedure
Primary	Volumetric plaque burden as measured by IVUS at four-months and twelve months post-procedure.		four-months and twelve months post-procedure
Primary	Four and twelve month target vessel failure (TVF).		Four and twelve month