Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Distal Protection Combined With PTCA in AMI Patients (DIPLOMAT)

This study has been completed.
Information provided by:
Cordis Corporation Identifier:
First received: December 9, 2005
Last updated: January 4, 2008
Last verified: January 2008
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 Intervention Phase
Coronary Artery Disease
Device: Angioguard distal protection device
Other: PTCA
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Distal Protection Combined With PTCA in AMI Patients -- The DIPLOMAT Study.

Further study details as provided by Cordis Corporation:

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

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

Enrollment: 56
Study Start Date: March 2002
Study Completion Date: August 2004
Arms Assigned Interventions
Other: PTCA
PTCA with angioguard
Device: Angioguard distal protection device
PTCA with the Angioguard distal protection device.
Other Name: Cordis AngioGuard™ XP

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00264030

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

Responsible Party: Dr. Hans-Peter Stoll - Director Clinical Affairs, Cordis Identifier: NCT00264030     History of Changes
Other Study ID Numbers: EC00-02
Study First Received: December 9, 2005
Last Updated: January 4, 2008

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases processed this record on April 24, 2017