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

Coronary Artery Disease Clinical Trial

— DISCOVER  

Official title:

Distal Protection Combined With Velocity in Coronary Arteries and SVBG Registry.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00264043
• Other study ID #: EC99-09
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 9, 2005
• Last updated: August 5, 2008
• Start date: May 2000
• Est. completion date: June 2002

Study information

• Verified date: August 2008
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: ethics kommission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2002
• Est. primary completion date: February 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• emboli capturing guidewire device combined with stent
AngioGuard™ device and Bx Velocity™ stent

Locations

Country	Name	City	State
Germany	Herzzentrum Siegburg GMBH	Siegburg

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical success of the AngioGuard™ device combined with the Bx Velocity™ stent		1 month	No
Secondary	successful placement and retrieval without embolic occlusions of vessels distal to the position of the device		post-procedure	Yes
Secondary	overall survival rates		1 month and 6 months	Yes
Secondary	device evaluation		post-procedure	No