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

About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
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).
Sites / Locations
- Herzzentrum Siegburg GMBH
Arms of the Study
Arm 1
Experimental
1
AngioGuard™ device and Bx Velocity™ stent