The Study to Evaluate Patient Outcome Using Distal Protection Combined With the BX Velocity.

Distal Protection Combined With Velocity in Coronary Arteries and SVBG Registry.

The primary objective is to evaluate the use of the AngioGuard™ device combined with the Bx Velocity™ on patient outcome at one month.

This is a prospective, non-randomized, multi-center trial. Patients will be treated with the AngioGuard™ device and Bx Velocity™ stent and will be followed for six-months post-procedure.

Inclusion Criteria:

• Unstable angina pectoris (Braunwald classification B & C, I-II-III, native vessels)
• or lesion located in the SVG;
• Single de novo or restenotic lesion requiring treatment in a major native coronary artery or saphenous vein graft;
• The vessel diameter to place the AngioGuard™ device in must be > 3 and < 5.5 mm (6.5 when the 7mm AngioGuard™ is available);
• Target lesion stenosis is >50% and <100% (TIMI 1).

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;
• More than one coronary artery is 100% occluded;
• Patient has unprotected left main coronary disease with > 50% stenosis;
• Patient has an ostial target lesion;
• Significant (>50%) untreated stenosis proximal or distal to the target lesion that will be treated during the procedure, since this may require revascularization or impede runoff;
• Ejection fraction <30%;
• Totally occluded vessel (TIMI 0 Level).