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

April 30, 2009 updated by: Masaryk University

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.

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Ústí nad Labem, Czech Republic, 40113
        • Department of Cardiology, Masaryk hospital and University of JEP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Acute STEMI within 12 hours from symptoms onset
  2. Native coronary disease with a lesion suitable for stenting
  3. Vessel size in between 2.5-3.75mm
  4. Patient is willing to provide written informed consent
  5. Male or female patients between 18-85 years of age

Exclusion Criteria:

  1. Significant left main disease
  2. Killip class IV
  3. Known allergy to aspirin and or clopidogrel/ticlopidine
  4. Recent bleeding (<1month)
  5. Patient in anticoagulant therapy
  6. No suitable coronary anatomy for OCT scan (ostial lesion, very distal or large vessel />3.75mm in diameter/)
  7. Pregnancy
  8. Severe liver or renal disease (Cr>2.0)
  9. Life expectancy < 1 year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Device: biolimus A9
200 patients with STEMI will be treated using Biomatrix stent.
Other Names:
  • biolimus A9 eluting stent
Active Comparator: 2
Device: everolimus
200 patients with STEMI will be treated with PROMUS DES.
Other Names:
  • everolimus eluting stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
to compare a safety and effectiveness of third generation DES (biolimus A9 and everolimus) in patients with STEMI treated by primary PCI with OCT guidance with assessment of a MACE's at 9 month follow-up
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
number of uncovered stent struts
Time Frame: 2 years
2 years
number of malaposed stents struts
Time Frame: 2 years
2 years
in-stent neointimal volume
Time Frame: 2 years
2 years
in-segment assessment of vessel wall response to DES
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masaryk University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Anticipated)

January 1, 2011

Study Completion (Anticipated)

May 1, 2011

Study Registration Dates

First Submitted

April 27, 2009

First Submitted That Met QC Criteria

April 27, 2009

First Posted (Estimate)

April 28, 2009

Study Record Updates

Last Update Posted (Estimate)

May 1, 2009

Last Update Submitted That Met QC Criteria

April 30, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06042006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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