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
  Purpose

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


Condition Intervention Phase
Coronary Artery Disease
Device: emboli capturing guidewire device combined with stent
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Distal Protection Combined With Velocity in Coronary Arteries and SVBG Registry.

Resource links provided by NLM:


Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • clinical success of the AngioGuard™ device combined with the Bx Velocity™ stent [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 100
Study Start Date: May 2000
Study Completion Date: June 2002
Primary Completion Date: February 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AngioGuard™ device and Bx Velocity™ stent
Device: emboli capturing guidewire device combined with stent
AngioGuard™ device and Bx Velocity™ stent
Other Names:
  • emboli capturing guidewire device
  • PTCA

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00264043

Locations
Germany
Herzzentrum Siegburg GMBH
Siegburg, Germany, 53721
Sponsors and Collaborators
Cordis Corporation
Investigators
Principal Investigator: Eberhard Grube, MD Herzzentrum Siegburg GMBH
  More Information

No publications provided

Responsible Party: Dr. Hans-Peter Stoll, Cordis
ClinicalTrials.gov Identifier: NCT00264043     History of Changes
Other Study ID Numbers: EC99-09
Study First Received: December 9, 2005
Last Updated: August 5, 2008
Health Authority: Germany: ethics kommission

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014