Distal Protection Combined With PTCA in AMI Patients

Phase 2

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Angioguard distal protection device; Other: PTCA

• Registration Number: NCT00264030
• Lead Sponsor: Cordis Corporation

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.

Study Timeline

• Study Start: 2002-03
• Study Completion: 2004-08
• Study First Submitted: 2005-12-09
• Study First Submitted QC: 2005-12-09
• Study First Posted: 2005-12-12
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-04
• Last Update Posted: 2008-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Angioguard distal protection device	PTCA with angioguard
1	PTCA	PTCA

Primary Outcome Measures

Name	Time	Method
Absolute ST segment resolution.	post-PTCA

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institut Cardiovasculaire Paris Sud; 🇫🇷 Massy, France