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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2009 by Masaryk University.
Recruitment status was:  Not yet recruiting
Information provided by:
Masaryk University Identifier:
First received: April 27, 2009
Last updated: April 30, 2009
Last verified: April 2009

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

Condition Intervention Phase
Coronary Heart Disease Percutaneous Coronary Intervention Device: biolimus A9 Device: everolimus Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by Masaryk University:

Primary Outcome Measures:
  • 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 ]

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

Estimated Enrollment: 400
Study Start Date: May 2009
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: biolimus A9
200 patients with STEMI will be treated using Biomatrix stent.
Other Name: biolimus A9 eluting stent
Active Comparator: 2 Device: everolimus
200 patients with STEMI will be treated with PROMUS DES.
Other Name: everolimus eluting stent

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.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00888758

Contact: Pavel Cervinka, MD,PhD +420477117886

Czech Republic
Department of Cardiology, Masaryk hospital and University of JEP Not yet recruiting
Ústí nad Labem, Czech Republic, 40113
Contact: Pavel Cervinka, MD,PhD    +420477117886   
Sub-Investigator: Petr Kala, MD,P hD         
Sub-Investigator: Ladislav Pesl, MD         
Sponsors and Collaborators
Masaryk University
Principal Investigator: Pavel Cervinka, MD, PhD Krajska zdravotni a.s., Masarzk hospital Usti nad Labem
  More Information

Responsible Party: Assoc. prof. Pavel Červinka, MD, PhD, FESC, FSCAI, Masaryk hospital and University of JEP Ústí nad Labem Identifier: NCT00888758     History of Changes
Other Study ID Numbers: 06042006
Study First Received: April 27, 2009
Last Updated: April 30, 2009

Keywords provided by Masaryk University:

Additional relevant MeSH terms:
Heart Diseases
Myocardial Infarction
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents processed this record on September 20, 2017