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DIPLOMAT: Distal Protection Combined With PTCA in AMI Patients

Sponsor
Cordis Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00264030
Collaborator
(none)
56
Enrollment
1
Location
2
Arms
29
Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Angioguard distal protection device
  • Other: PTCA
 Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single
Primary Purpose:
Treatment
Official Title:
Distal Protection Combined With PTCA in AMI Patients -- The DIPLOMAT Study.
Study Start Date :
Mar 1, 2002
Actual Study Completion Date :
Aug 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Other: 1

PTCA

Other: PTCA
PTCA
Other: 2

PTCA with angioguard

Device: Angioguard distal protection device
PTCA with the Angioguard distal protection device.
Other Names:
  • Cordis AngioGuard™ XP

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Absolute ST segment resolution. [post-PTCA]

    Secondary Outcome Measures

    1. ST segment resolution (> 50% decrease). [pre- and post-PTCA]

    2. TIMI Frame Count [post PTCA]

    3. Composite endpoint of slow flow, no reflow or distal embolization. [at anytime]

    4. Regional wall motion index by echocardiography. [discharge and 6 month follow-up]

    5. Clinical success evaluation; qualitative evaluation of device and delivery system characteristics. [post-procedure]

    6. Cardiac function assessed by echocardiography. [before discharge and at 6 month follow-up]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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:

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institut Cardiovasculaire Paris Sud Massy France F - 91300

    Sponsors and Collaborators

    • Cordis Corporation

    Investigators

    • Principal Investigator: Thierry LEFEVRE, MD, Hopital Tarnier-Cochin

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00264030
    Other Study ID Numbers:
    • EC00-02
    First Posted:
    Dec 12, 2005
    Last Update Posted:
    Jan 7, 2008
    Last Verified:
    Jan 1, 2008
    Additional relevant MeSH terms:
    Coronary Artery Disease

    Study Results

    No Results Posted as of Jan 7, 2008