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
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 April 17, 2014