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

NCT00888758 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2009-05-01

No results posted yet for this study

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Masaryk University

    lead OTHER

Principal Investigators

  • Pavel Cervinka, MD, PhD · Krajska zdravotni a.s., Masarzk hospital Usti nad Labem

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-01-31
Completion
2011-05-31

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00888758 on ClinicalTrials.gov