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

Cordis

Status and phase

Completed

Phase 3

Phase 2

Conditions

Coronary Artery Disease

Treatments

Device: emboli capturing guidewire device combined with stent

Study type

Interventional

Funder types

Industry

Identifiers

NCT00264043

EC99-09

Details and patient eligibility

About

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

Full description

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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).