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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014