Prospective, multicenter registries using the FilterWire EZ™ Embolic Protection System. The vessel size range in the BLAZE Registry was 3.5 mm to 5.5 mm and the vessel size range in the BLAZE II Registry was 2.25 mm to 3.5 mm.
For the complete BLAZE Clinical Registry data in portable document format (PDF),
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| Objective: |
To evaluate the safety and performance of the Boston Scientific FilterWire EZ™ Embolic Protection System during angioplasty/stenting of saphenous vein grafts (SVGs). |
| Number of Patients: |
221 (BLAZE = 90; BLAZE II = 131) |
| Lesion Type: |
Saphenous Vein Grafts (SVGs) |
| Platform: |
FilterWire EZ™ Embolic Protection System |
| Primary Endpoint: |
The primary safety end point of both studies was the cumulative incidence of major adverse cardiac events (MACE), defined as death, Q-wave or non-Q-wave myocardial infarction (MI), emergent coronary artery bypass surgery (CABG), or target vessel revascularization (TVR), at 30-days post-procedure. |
| P.I. and Co-P.I.: |
D. Cox, MD and G. Stone, MD |
| Status: |
Enrollment Complete |
