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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00264043

Acronym

DISCOVER

Enrollment

100

Registered

2005-12-12

Start date

2000-05-31

Completion date

2002-06-30

Last updated

2008-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

DEVICEemboli capturing guidewire device combined with stent

AngioGuard™ device and Bx Velocity™ stent

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026