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

Sponsored by:	Cordis Corporation
Information provided by:	Cordis Corporation
ClinicalTrials.gov Identifier:	NCT00233766

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Disease	Device: Bx VELOCITY Stent containing 45% and 70% of Sirolimus dose	Phase I Phase II

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Sirolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy 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)

Further study details as provided by Cordis Corporation:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	60
Study Start Date:	September 2002
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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;

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233766

Locations

Brazil
Instituto Dante Pazzanese de Cardiologia
Sao Paolo, Brazil

Sponsors and Collaborators

Cordis Corporation

Investigators

Principal Investigator:

J. E. Sousa, MD

Instituto Dante Pazzanese de Cardiologia

More Information

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 Jul 9; [Epub ahead of print]

Responsible Party:	Instituto Dante Pazzanese de Cardiologia ( J. E. Sousa, MD )
Study ID Numbers:	P02-6314
Study First Received:	October 4, 2005
Last Updated:	April 17, 2008
ClinicalTrials.gov Identifier:	NCT00233766
Health Authority:	Brazil: National Committee of Ethics in Research

Study placed in the following topic categories:

Sirolimus
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Clotrimazole
Miconazole

Myocardial Ischemia
Tioconazole
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Anti-Bacterial Agents
Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents
Antifungal Agents
Therapeutic Uses

Physiological Effects of Drugs
Cardiovascular Diseases
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009