Status:
COMPLETED
The Study to Evaluate Patient Outcome Using Distal Protection Combined With the BX Velocity.
Lead Sponsor:
Cordis US Corp.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The primary objective is to evaluate the use of the AngioGuard™ device combined with the Bx Velocity™ on patient outcome at one month.
Detailed 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.
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2002
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00264043
Start Date
May 1 2000
End Date
June 1 2002
Last Update
August 6 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Herzzentrum Siegburg GMBH
Siegburg, Germany, 53721