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

NCT ID: NCT00264043

Last Updated: 2008-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-05-31

Study Completion Date

2002-06-30

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

AngioGuard™ device and Bx Velocity™ stent

Group Type EXPERIMENTAL

emboli capturing guidewire device combined with stent

Intervention Type DEVICE

AngioGuard™ device and Bx Velocity™ stent

Interventions

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emboli capturing guidewire device combined with stent

AngioGuard™ device and Bx Velocity™ stent

Intervention Type DEVICE

Other Intervention Names

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emboli capturing guidewire device PTCA

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cordis Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Cordis

Principal Investigators

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Eberhard Grube, MD

Role: PRINCIPAL_INVESTIGATOR

Herzzentrum Siegburg GMBH

Locations

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Herzzentrum Siegburg GMBH

Siegburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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EC99-09

Identifier Type: -

Identifier Source: org_study_id