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

NCT00264043 | Completed Phase 2 DMC

• 1 other identifier: EC99-09
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

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

  1 month

Secondary Outcomes (3)

• 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

Study Arms (1)

1

EXPERIMENTAL

AngioGuard™ device and Bx Velocity™ stent

Device: emboli capturing guidewire device combined with stent

Interventions

emboli capturing guidewire device combined with stent DEVICE

AngioGuard™ device and Bx Velocity™ stent

Also known as: emboli capturing guidewire device, PTCA

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cordis US Corp.: lead

Study Sites (1)

Herzzentrum Siegburg GMBH

Siegburg, 53721, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Eberhard Grube, MD

  Herzzentrum Siegburg GMBH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 9, 2005
• First Posted: December 12, 2005
• Study Start: May 1, 2000
• Primary Completion: February 1, 2002
• Study Completion: June 1, 2002
• Last Updated: August 6, 2008

Record last verified: 2008-08

Locations

DE (1)