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

Phase 2

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: emboli capturing guidewire device combined with stent

• Registration Number: NCT00264043
• Lead Sponsor: Cordis Corporation

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.

Study Timeline

• Study Start: 2000-05
• Primary Completion: 2002-02
• Study Completion: 2002-06
• Study First Submitted: 2005-12-09
• Study First Submitted QC: 2005-12-09
• Study First Posted: 2005-12-12
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-05
• Last Update Posted: 2008-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	emboli capturing guidewire device combined with stent	AngioGuard™ device and Bx Velocity™ stent

Primary Outcome Measures

Name	Time	Method
clinical success of the AngioGuard™ device combined with the Bx Velocity™ stent	1 month

Secondary Outcome Measures

Name	Time	Method
device evaluation	post-procedure
successful placement and retrieval without embolic occlusions of vessels distal to the position of the device	post-procedure
overall survival rates	1 month and 6 months

Trial Locations

Locations (1)

Herzzentrum Siegburg GMBH; 🇩🇪 Siegburg, Germany