Distal Protection Combined With PTCA in AMI Patients -- The DIPLOMAT Study.

Cordis Corporation1 site in 1 country56 target enrollmentMarch 2002

ConditionsCoronary Artery Disease

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Cordis Corporation
Enrollment: 56
Locations: 1
Primary Endpoint: Absolute ST segment resolution.
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

March 2002

End Date

August 2004

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cordis Corporation

Eligibility 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.

Outcomes

Primary Outcomes

Absolute ST segment resolution.

Time Frame: post-PTCA

Secondary Outcomes

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