Distal Protection Combined With PTCA in AMI Patients (DIPLOMAT)

January 4, 2008 updated by: Cordis Corporation

Distal Protection Combined With PTCA in AMI Patients -- The DIPLOMAT Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Massy, France, F - 91300
        • Institut Cardiovasculaire Paris Sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absolute ST segment resolution.
Time Frame: post-PTCA
post-PTCA

Secondary Outcome Measures

Outcome Measure
Time Frame
ST segment resolution (> 50% decrease).
Time Frame: pre- and post-PTCA
pre- and post-PTCA
TIMI Frame Count
Time Frame: post PTCA
post PTCA
Composite endpoint of slow flow, no reflow or distal embolization.
Time Frame: at anytime
at anytime
Regional wall motion index by echocardiography.
Time Frame: discharge and 6 month follow-up
discharge and 6 month follow-up
Clinical success evaluation; qualitative evaluation of device and delivery system characteristics.
Time Frame: post-procedure
post-procedure
Cardiac function assessed by echocardiography.
Time Frame: before discharge and at 6 month follow-up
before discharge and at 6 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cordis Corporation

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

December 9, 2005

First Submitted That Met QC Criteria

December 9, 2005

First Posted (Estimate)

December 12, 2005

Study Record Updates

Last Update Posted (Estimate)

January 7, 2008

Last Update Submitted That Met QC Criteria

January 4, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC00-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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