FIM-BR - First-in-Man Study (Brazil Part) With Sirolimus-Coated BX VELOCITY Stent

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: sirolimus coated Bx VELOCITY stent - fast release
* Device: sirolimus coated Bx VELOCITY stent - slow release


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS) or a positive ischemia study; Single de novo or restenotic lesion requiring treatment in a major native coronary artery; 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; Unprotected left main coronary disease with >=50% stenosis; Have an ostial target lesion; Angiographic evidence of thrombus within target lesion; Calcified lesions which cannot be successfully predilated; Ejection fraction <=30%; Target lesion involves bifurcation (either stenosis of both main vessel and major branch or stenosis of just major branch); Totally occluded vessel;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>sirolimus coated Bx VELOCITY stent - fast release | Device: sirolimus coated Bx VELOCITY stent - fast release<br> <br> |
| Other: 2<br>sirolimus coated Bx VELOCITY stent - slow release | Device: sirolimus coated Bx VELOCITY stent - slow release<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of in-stent percent diameter stenosis (%DS) measured by quantitative coronary angiography. |  | post procedure and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of lesion morphology by intravascular ultrasound (IVUS). |  | post procedure and 6 months | 
| Target vessel failure (TVF). |  | 6 months |