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

Phase 1

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: sirolimus coated Bx VELOCITY stent - fast release; Device: sirolimus coated Bx VELOCITY stent - slow release

• Registration Number: NCT00233792
• Lead Sponsor: Cordis Corporation

Brief Summary

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

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.

Study Timeline

• Study Start: 1999-12
• Study Completion: 2005-03
• Study First Submitted: 2005-10-04
• Study First Submitted QC: 2005-10-05
• Study First Posted: 2005-10-06
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-11
• Last Update Posted: 2007-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	sirolimus coated Bx VELOCITY stent - fast release	sirolimus coated Bx VELOCITY stent - fast release
2	sirolimus coated Bx VELOCITY stent - slow release	sirolimus coated Bx VELOCITY stent - slow release

Primary Outcome Measures

Name	Time	Method
Assessment of in-stent percent diameter stenosis (%DS) measured by quantitative coronary angiography.	post procedure and 6 months

Secondary Outcome Measures

Name	Time	Method
Target vessel failure (TVF).	6 months
Assessment of lesion morphology by intravascular ultrasound (IVUS).	post procedure and 6 months

Trial Locations

Locations (1)

Instituto Dante Pazzanese of Cardiology; 🇧🇷 Sao Paulo, Brazil