Distal Protection Combined With PTCA in AMI Patients

Cordis US Corp.56 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Coronary Artery Disease

Interventions

Angioguard distal protection deviceDEVICE

PTCA with the Angioguard distal protection device.

PTCAOTHER

PTCA

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Institut Cardiovasculaire Paris Sud

Massy, France

Outcomes

Primary Outcomes

Absolute ST segment resolution.

Time frame: post-PTCA

Secondary Outcomes

ST segment resolution (> 50% decrease).

Time frame: pre- and post-PTCA

TIMI Frame Count

Time frame: post PTCA

Composite endpoint of slow flow, no reflow or distal embolization.

Time frame: at anytime

Regional wall motion index by echocardiography.

Time frame: discharge and 6 month follow-up

Clinical success evaluation; qualitative evaluation of device and delivery system characteristics.

Time frame: post-procedure

Cardiac function assessed by echocardiography.

Time frame: before discharge and at 6 month follow-up

Data from ClinicalTrials.gov

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