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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
emboli capturing guidewire device combined with stent
Sponsored by
Cordis Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Herzzentrum Siegburg GMBH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

AngioGuard™ device and Bx Velocity™ stent

Outcomes

Primary Outcome Measures

clinical success of the AngioGuard™ device combined with the Bx Velocity™ stent

Secondary Outcome Measures

successful placement and retrieval without embolic occlusions of vessels distal to the position of the device
overall survival rates
device evaluation

Full Information

First Posted
December 9, 2005
Last Updated
August 5, 2008
Sponsor
Cordis Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00264043
Brief Title
The Study to Evaluate Patient Outcome Using Distal Protection Combined With the BX Velocity.
Acronym
DISCOVER
Official Title
Distal Protection Combined With Velocity in Coronary Arteries and SVBG Registry.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
May 2000 (undefined)
Primary Completion Date
February 2002 (Actual)
Study Completion Date
June 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cordis Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
AngioGuard™ device and Bx Velocity™ stent
Intervention Type
Device
Intervention Name(s)
emboli capturing guidewire device combined with stent
Other Intervention Name(s)
emboli capturing guidewire device, PTCA
Intervention Description
AngioGuard™ device and Bx Velocity™ stent
Primary Outcome Measure Information:
Title
clinical success of the AngioGuard™ device combined with the Bx Velocity™ stent
Time Frame
1 month
Secondary Outcome Measure Information:
Title
successful placement and retrieval without embolic occlusions of vessels distal to the position of the device
Time Frame
post-procedure
Title
overall survival rates
Time Frame
1 month and 6 months
Title
device evaluation
Time Frame
post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eberhard Grube, MD
Organizational Affiliation
Herzzentrum Siegburg GMBH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herzzentrum Siegburg GMBH
City
Siegburg
ZIP/Postal Code
53721
Country
Germany

12. IPD Sharing Statement

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

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