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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2014