Distal Protection Combined With PTCA in AMI Patients (DIPLOMAT)

Cordis

Status and phase

Completed

Phase 2

Conditions

Coronary Artery Disease

Treatments

Device: Angioguard distal protection device

Other: PTCA

Study type

Interventional

Funder types

Industry

Identifiers

NCT00264030

EC00-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

56 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.