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

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ClinicalTrials.gov Identifier: NCT00888758
Recruitment Status : Unknown
Verified April 2009 by Masaryk University.
Recruitment status was:  Not yet recruiting
First Posted : April 28, 2009
Last Update Posted : May 1, 2009
Sponsor:
Information provided by:

Study Description
Brief 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

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Percutaneous Coronary Intervention Device: biolimus A9 Device: everolimus Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
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.
Study Start Date : May 2009
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. number of uncovered stent struts [ Time Frame: 2 years ]
  2. number of malaposed stents struts [ Time Frame: 2 years ]
  3. in-stent neointimal volume [ Time Frame: 2 years ]
  4. in-segment assessment of vessel wall response to DES [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00888758


Contacts
Contact: Pavel Cervinka, MD,PhD +420477117886 pavel.cervinka@mnul.cz

Locations
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    pavel.cervinka@mnul.cz   
Sub-Investigator: Petr Kala, MD,P hD         
Sub-Investigator: Ladislav Pesl, MD         
Sponsors and Collaborators
Masaryk University
Investigators
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
ClinicalTrials.gov Identifier: NCT00888758     History of Changes
Other Study ID Numbers: 06042006
First Posted: April 28, 2009    Key Record Dates
Last Update Posted: May 1, 2009
Last Verified: April 2009

Keywords provided by Masaryk University:
Stents

Additional relevant MeSH terms:
Infarction
Heart Diseases
Myocardial Infarction
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Everolimus
Sirolimus
Umirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Anti-Inflammatory Agents