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CompletedNCT00264030DIPLOMATUpdated Jan 7, 2008

Distal Protection Combined With PTCA in AMI Patients

A Phase 2 interventional study of Angioguard distal protection device and PTCA in Coronary Artery Disease, sponsored by Cordis Corporation. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-01-07.

Sponsored by Cordis Corporation · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

This is a prospective, randomized, multicenter trial. Patients will be randomized either to be treated by PTCA only or in combination with the An-gioGuard™ XP device. The patients will be followed for six-months post-procedure.

02

Conditions studied

  • Coronary Artery Disease
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 56 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Cordis Corporation is the lead sponsor of 70 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
56 participants (actual)

Study arms

  • Other
    1

    PTCA

    Other: PTCA

  • Other
    2

    PTCA with angioguard

    Device: Angioguard distal protection device

Interventions

  • DeviceAngioguard distal protection device

    PTCA with the Angioguard distal protection device.

    Also known as: Cordis AngioGuard™ XP

  • OtherPTCA

    PTCA

06

What researchers measure

Primary outcomes

  1. Absolute ST segment resolution.

    Time frame: post-PTCA

Secondary outcomes

  1. ST segment resolution (> 50% decrease).

    Time frame: pre- and post-PTCA

  2. TIMI Frame Count

    Time frame: post PTCA

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

    Time frame: at anytime

  4. Regional wall motion index by echocardiography.

    Time frame: discharge and 6 month follow-up

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

    Time frame: post-procedure

  6. Cardiac function assessed by echocardiography.

    Time frame: before discharge and at 6 month follow-up

07

Study locations

1 site
  • Institut Cardiovasculaire Paris Sud
    Massy, F - 91300, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00264030
Lead sponsor
Cordis Corporation
First posted
Dec 12, 2005
Start date
Mar 2002
Completion
Aug 2004
Last update
Jan 7, 2008

Study contacts

Thierry LEFEVRE, MD
principal investigator · Hopital Tarnier-Cochin

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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