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Sponsored by: |
Cordis Corporation |
Information provided by: | Cordis Corporation |
ClinicalTrials.gov Identifier: | NCT00233792 |
This is a single center, non-randomized study. Patients will be treated with the sirolimus coated Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor OTW SDS. Patients will have a repeat angiography at four months and will be followed for twelve months post-procedure.
Condition | Intervention | Phase |
Coronary Artery Disease |
Device: sirolimus coated Bx VELOCITY stent - fast release Device: sirolimus coated Bx VELOCITY stent - slow release |
Phase I Phase II |
MedlinePlus related topics: | Coronary Artery Disease |
ChemIDplus related topics: | Sirolimus |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Evaluation of the Sirolimus Coated Modified BX VELOCITY Balloon-Expandable Stent in the Treatment of Patients With de Novo or Restenotic Native Coronary Artery Lesions. |
Enrollment: | 30 |
Study Start Date: | December 1999 |
Study Completion Date: | March 2005 |
Arms | Assigned Interventions |
1
sirolimus coated Bx VELOCITY stent - fast release
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Device: sirolimus coated Bx VELOCITY stent - fast release |
2
sirolimus coated Bx VELOCITY stent - slow release
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Device: sirolimus coated Bx VELOCITY stent - slow release |
This is a single center, non-randomized study of the Bx VELOCITY Balloon-Expandable Stent coated with sirolimus (140µg/cm2) and formulated for fast or slow release. The sirolimus coated stent is mounted on the Raptor OTW SDS. Approximately 30 patients with de novo or restenotic native coronary artery lesions <=18mm in length and >=3.0 to >=3.5 mm in diameter by visual estimate who meet all eligibility criteria will be treated with the sirolimus coated Bx VELOCITY stent(s). Patients will be followed for five years post-procedure and will have a repeat angiography at 4 months, 12 months, 24 months, and 48 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Brazil | |||||
Instituto Dante Pazzanese of Cardiology | |||||
Sao Paulo, Brazil, 04012-909 |
Cordis Corporation |
Principal Investigator: | Eduardo J Sousa, MD | Instituto Dante Pazzanese of Cardiology |
Study ID Numbers: | P99-6301 |
First Received: | October 4, 2005 |
Last Updated: | October 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00233792 |
Health Authority: | Brazil: National Committee of Ethics in Research |
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