NCT00233818

FIM-NL - First-in-Man Study (Netherlands Part) With Sirolimus Coated Modified BX Velocity Stent

An Evaluation of Sirolimus-Coated Modified BX VELOCITY Balloon-Expandable Stents for the Treatment of Patients With de Novo Native Coronary Artery Lesions

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Cordis US Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess the performance and safety of a formulation of the antiproliferative agent, sirolimus coated on modified Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor Over The Wire (OTW) Stent Delivery System (SDS) in patients with de novo coronary artery lesions.

Detailed description

This is a single center, non-randomized study. Patients who meet the eligibility criteria will be treated with the sirolimus coated modified Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor OTW SDS. Patients will be followed for five years post-procedure, with all patients having a repeat angiography at 6 months, 18 months, and 48 months.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Sirolimus-coated Bx VELOCITY Stent

Timeline

• Start date: 2000-02-01
• Completion: 2005-06-01
• First posted: 2005-10-06
• Last updated: 2007-10-12

Locations

1 site across 1 country: Netherlands