NCT01008085

STENTYS Self-expanding Versus Balloon-expandable Stent in Acute Myocardial Infarction (AMI)

Randomized Comparison Between the STENTYS Self-expanding Coronary Stent and a Balloon-expandable Stent in Acute Myocardial Infarction - APPOSITION II

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Stentys · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study hypothesis: the Stentys self-expandable Stent results into a better alignment of the struts to the vessel wall than a balloon-expandable stent within a few days after the procedure in acute myocardial infarction patients.

Detailed description

Stent strut malapposition and stent underexpansion are a common phenomenon in AMI as a result of the changing anatomy after an AMI has occurred (thrombus dissolution, resolution of spasm) with the traditional balloon-expandable stent treatment. A self-expanding stent might lead to better stent strut apposition as it follows the contours of the vessel wall due to its self-expanding properties. This might result into better long term clinical outcomes like lower thrombosis rates.

Conditions

• STEMI

Interventions

Type	Name	Description
DEVICE	Stentys coronary stent	Self-expanding Nitinol stent
DEVICE	Balloon-expandable stent	VISION/Driver

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-06-01
• Completion: 2010-12-01
• First posted: 2009-11-05
• Last updated: 2011-01-24

Locations

1 site across 1 country: France