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Completed

NCT Number: NCT00233766

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Instituto Dante Pazzanese de Cardiologia

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Bx VELOCITY Stent containing 45% and 70% of Sirolimus dose

Device

Primary outcomes

  1. Late loss measured by quantitative coronary angiography at four-months and twelve-months post-procedure.

    Time frame: four-months and twelve-months post-procedure

  2. 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

  3. Volumetric plaque burden as measured by IVUS at four-months and twelve months post-procedure.

    Time frame: four-months and twelve months post-procedure

  4. Four and twelve month target vessel failure (TVF).

    Time frame: Four and twelve month

Sponsors and collaborators

Lead sponsor

Cordis US Corp.

Industry

Registry information

Official study 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)

Important dates

Study start
2002
Primary completion
2007
Study completion
2007
First posted
Oct 6, 2005
Registry last updated
Apr 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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