PRoximal Embolic Protection in Acute myocardial infarction and Resolution of ST-Elevation-combined embolic protection and thrombectomy during percutaneous coronary intervention in acute ST-segment elevation myocardial infarction: a randomised comparison using the PROXIS™ device

Completed

• Conditions: Myocardial infarction; Circulatory System; Ischaemic heart diseases

• Registration Number: ISRCTN71104460
• Lead Sponsor: Academic Medical Centre (AMC) (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-05
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 280

Inclusion Criteria

Consecutive patients with an acute ST-segment elevation MI undergoing primary PCI:
1. Primary PCI within six hours after onset of symptoms of myocardial infarction
2. Electrocardiographic evidence of persistent ST-segment elevation of at least 0.1 mV in two or more contiguous leads at the time of randomisation
3. Proximal obstruction of infarct related coronary artery with TIMI zero to two flow with minimal diameter of 2.5 mm or more
4. The obstruction is amenable to the use of the PROXIS™ as judged by an experienced operator

Exclusion Criteria

1. Younger than 18 years of age
2. Use of a thrombolytic agent within the previous 48 hours
3. Prior coronary artery bypass graft (CABG)
4. Contraindications to the use of a glycoprotein (GP) IIb/IIIa inhibitor
5. Co-existent condition associated with a limited life expectancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of this study is a more than 70% resolution of ST-segment elevation at one hour after PCI, compared to ST-segment elevation immediately prior to PCI.