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Distal Protection Combined With PTCA in AMI Patients (DIPLOMAT)

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ClinicalTrials.gov Identifier: NCT00264030
Recruitment Status : Completed
First Posted : December 12, 2005
Last Update Posted : January 7, 2008
Sponsor:
Information provided by:
Cordis Corporation

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
Coronary Artery Disease 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 Type : Interventional  (Clinical Trial)
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 : March 2002
Actual Study Completion Date : August 2004

Arm Intervention/treatment
1
PTCA
Other: PTCA
PTCA
2
PTCA with angioguard
Device: Angioguard distal protection device
PTCA with the Angioguard distal protection device.
Other Name: Cordis AngioGuard™ XP



Primary Outcome Measures :
  1. Absolute ST segment resolution. [ Time Frame: post-PTCA ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00264030


Locations
France
Institut Cardiovasculaire Paris Sud
Massy, France, F - 91300
Sponsors and Collaborators
Cordis Corporation
Investigators
Principal Investigator: Thierry LEFEVRE, MD Hopital Tarnier-Cochin

Responsible Party: Dr. Hans-Peter Stoll - Director Clinical Affairs, Cordis
ClinicalTrials.gov Identifier: NCT00264030     History of Changes
Other Study ID Numbers: EC00-02
First Posted: December 12, 2005    Key Record Dates
Last Update Posted: January 7, 2008
Last Verified: January 2008

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases