NCT00888758

Comparison of Biolimus A9 and Everolimus Drug-Eluting Stents in Patients With ST Segment Elevation Myocardial Infarction

Randomized Comparison of Biolimus-Eluting and Everolimus-Eluting Stents With Optical Coherence Tomography Guided Stent Implantation in ST Elevation Myocardial Infarction.A 9-Month Angiographic and Optical Coherence Tomography Follow-up.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Masaryk University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is: * comparison of a safety and effectiveness of third generation DES (biolimus A9 and everolimus) in patients with STEMI treated by primary PCI with OCT guidance. A rate of 9 month MACE (deaths, myocardial infarction, ischemia driven TLR) will be assessed in both groups. The secondary outcomes are a comparison of (using OCT): * number of uncovered stent struts * number of malapposed stents struts * in-stent neointimal volume * in-segment assessment of vessel wall response to DES

Detailed description

The aim of this multicenter, prospective, randomized trial with a core lab analysis is to assess the safety and effectiveness (at 9-month follow-up) of third generation DES (biolimus A9 and everolimus) in patients with evolving STEMI with the OCT guidance (to optimize a stent implantation) A serial OCT analysis will be performed to assess the number of either uncovered or malaposed stents strut and a degree of in-stent neointimal hyperplasia. Furthermore, the in-segment vessel wall response to DES implantation will also be analysed. The goal is to enroll 400 patients (200 in each group) with OCT guidance in 100 patients in each group.

Conditions

• Coronary Heart Disease
• Percutaneous Coronary Intervention

Interventions

Type	Name	Description
DEVICE	biolimus A9	200 patients with STEMI will be treated using Biomatrix stent.
DEVICE	everolimus	200 patients with STEMI will be treated with PROMUS DES.

Timeline

• Start date: 2009-05-01
• Primary completion: 2011-01-01
• Completion: 2011-05-01
• First posted: 2009-04-28
• Last updated: 2009-05-01

Locations

1 site across 1 country: Czechia