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

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00233766
First received: October 4, 2005
Last updated: April 17, 2008
Last verified: April 2008
  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 1
Phase 2

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

Resource links provided by NLM:


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:

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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 17, 2014