Distal Protection Combined With PTCA in AMI Patients - Full Text View

Sponsored by:	Cordis Corporation
Information provided by:	Cordis Corporation
ClinicalTrials.gov Identifier:	NCT00264030

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 II

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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 ] [ 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.

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

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

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009