NCT00264030

Brief Summary

The primary objective is to evaluate if use of the AngioGuard™ XP improves myocardial reperfusion after PTCA as assessed by ST segment resolution at the end of PTCA.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_2 coronary-artery-disease

Timeline
Completed

Started Mar 2002

Typical duration for phase_2 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2005

Completed
Last Updated

January 7, 2008

Status Verified

January 1, 2008

First QC Date

December 9, 2005

Last Update Submit

January 4, 2008

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Absolute ST segment resolution.

    post-PTCA

Secondary Outcomes (6)

  • ST segment resolution (> 50% decrease).

    pre- and post-PTCA

  • TIMI Frame Count

    post PTCA

  • Composite endpoint of slow flow, no reflow or distal embolization.

    at anytime

  • Regional wall motion index by echocardiography.

    discharge and 6 month follow-up

  • Clinical success evaluation; qualitative evaluation of device and delivery system characteristics.

    post-procedure

  • +1 more secondary outcomes

Study Arms (2)

1

OTHER

PTCA

Other: PTCA

2

OTHER

PTCA with angioguard

Device: Angioguard distal protection device

Interventions

Angioguard distal protection deviceDEVICE

PTCA with the Angioguard distal protection device.

Also known as: Cordis AngioGuard™ XP
2
PTCAOTHER

PTCA

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute myocardial infarction \< 12 hours with ST segment elevation \> 2 mm in at least 2 contiguous leads;
  • Clinical indication of primary PTCA;
  • De novo or restenotic lesions in native coronary vessel, single vessel treatment only;
  • Target lesion stenosis is \> 80% (by visual estimation).

You may not qualify if:

  • Patient has unprotected left main coronary disease with \> 50% stenosis in case left coronary artery is treated;
  • Patient has an ostial target lesion;
  • Killip class \> 3.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Cardiovasculaire Paris Sud

Massy, F - 91300, France

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Thierry LEFEVRE, MD

    Hopital Tarnier-Cochin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 9, 2005

First Posted

December 12, 2005

Study Start

March 1, 2002

Study Completion

August 1, 2004

Last Updated

January 7, 2008

Record last verified: 2008-01

Locations

FR(1)