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

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

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: emboli capturing guidewire device combined with stent

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Germany
  • Siegburg, Germany, 53721
    • Herzzentrum Siegburg GMBH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; AngioGuard™ device and Bx Velocity™ stent	Device: emboli capturing guidewire device combined with stent; AngioGuard™ device and Bx Velocity™ stent; Other Names: PTCA; emboli capturing guidewire device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
clinical success of the AngioGuard™ device combined with the Bx Velocity™ stent	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
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
device evaluation	post-procedure

Collaborators and Investigators

• Sponsor: Cordis Corporation
• Investigators: Principal Investigator: Eberhard Grube, MD, Herzzentrum Siegburg GMBH

Study record dates

Study Major Dates

• Study Start: May 1, 2000
• Primary Completion (Actual): February 1, 2002
• Study Completion (Actual): June 1, 2002

Study Registration Dates

• First Submitted: December 9, 2005
• First Submitted That Met QC Criteria: December 9, 2005
• First Posted (Estimate): December 12, 2005

Study Record Updates

• Last Update Posted (Estimate): August 6, 2008
• Last Update Submitted That Met QC Criteria: August 5, 2008
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: EC99-09