Drug Eluting Balloon in Acute Myocardial Infarctio

Phase 4

Completed

• Conditions: coronary disease; myocardial infarction; 10011082

• Registration Number: NL-OMON35144
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

- Age: 18-80 year
- STEMI within 12 hours of onset of complaints
- Candidate for primary PCI with stent-implantation
- Successful thrombus aspiration defined by no angiographic signs of thrombus a the site of plaque rupture and TIMI flow * 1.

Exclusion Criteria

- Unable to give written informed consent
- Previous PCI or CABG of infarct related vessel
- Left main stenosis * 50%.
- Severe triple vessel disease with stenosis * 50% in 3 epicardial coronary arteries.
- Target vessel reference diameter < 2.5 and > 4.0 mm
- Target lesion length < 25 mm
- Intolerance for aspirin or clopidogrel
- Life expentancy < 12 month

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Late loss of lumen diameter between index procedure and 6 month angiographic<br /><br>follow-up.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Binary restenosis ( > 50 % ) at 6 month follow*up<br /><br>2) Stent malapposition at 6 month follow*up<br /><br>3) Endothelial dysfunction at 6 month follow*up<br /><br>4) Clinical outcome at 1 and 5 year follow*up</p><br>