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

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00264043
First received: December 9, 2005
Last updated: August 5, 2008
Last verified: August 2008

December 9, 2005
August 5, 2008
May 2000
February 2002   (final data collection date for primary outcome measure)
clinical success of the AngioGuard™ device combined with the Bx Velocity™ stent [ Time Frame: 1 month ] [ Designated as safety issue: No ]
The primary endpoint is to evaluate the clinical success of the AngioGuard™ device combined with the Bx Velocity™ stent on patient outcomes at one (1) month. Clinical success is defined as a composite of technical success – the successful access an
Complete list of historical versions of study NCT00264043 on ClinicalTrials.gov Archive Site
  • successful placement and retrieval without embolic occlusions of vessels distal to the position of the device [ Time Frame: post-procedure ] [ Designated as safety issue: Yes ]
  • overall survival rates [ Time Frame: 1 month and 6 months ] [ Designated as safety issue: Yes ]
  • device evaluation [ Time Frame: post-procedure ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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.

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

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.

Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
Device: emboli capturing guidewire device combined with stent
AngioGuard™ device and Bx Velocity™ stent
Other Names:
  • emboli capturing guidewire device
  • PTCA
Experimental: 1
AngioGuard™ device and Bx Velocity™ stent
Intervention: Device: emboli capturing guidewire device combined with stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
June 2002
February 2002   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00264043
EC99-09
Yes
Dr. Hans-Peter Stoll, Cordis
Cordis Corporation
Not Provided
Principal Investigator: Eberhard Grube, MD Herzzentrum Siegburg GMBH
Cordis Corporation
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP