Distal Protection Combined With PTCA in AMI Patients (DIPLOMAT)

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00264030
First received: December 9, 2005
Last updated: January 4, 2008
Last verified: January 2008
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Distal Protection Combined With PTCA in AMI Patients -- The DIPLOMAT Study.

Resource links provided by NLM:


Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • Absolute ST segment resolution. [ Time Frame: post-PTCA ] [ Designated as safety issue: Yes ]

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

Enrollment: 56
Study Start Date: March 2002
Study Completion Date: August 2004
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  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 ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Dr. Hans-Peter Stoll - Director Clinical Affairs, Cordis
ClinicalTrials.gov Identifier: NCT00264030     History of Changes
Other Study ID Numbers: EC00-02
Study First Received: December 9, 2005
Last Updated: January 4, 2008
Health Authority: France: Comite Consultatif de Proection de Personnes dans la Recherche Biomedicale

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

ClinicalTrials.gov processed this record on July 29, 2014