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

• successful placement and retrieval without embolic occlusions of vessels distal to the position of the device [ Time Frame: post-procedure ] [ Designated as safety issue: Yes ]
• overall survival rates [ Time Frame: 1 month and 6 months ] [ Designated as safety issue: Yes ]
• device evaluation [ Time Frame: post-procedure ] [ Designated as safety issue: No ]

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).