Comparison of Biolimus A9 and Everolimus Drug-Eluting Stents in Patients With ST Segment Elevation Myocardial Infarction
ROBUST
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.
1 other identifier
interventional
400
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2009
CompletedFirst Posted
Study publicly available on registry
April 28, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedMay 1, 2009
April 1, 2009
1.7 years
April 27, 2009
April 30, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
2 years
Secondary Outcomes (4)
number of uncovered stent struts
2 years
number of malaposed stents struts
2 years
in-stent neointimal volume
2 years
in-segment assessment of vessel wall response to DES
2 years
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
200 patients with STEMI will be treated using Biomatrix stent.
200 patients with STEMI will be treated with PROMUS DES.
Eligibility Criteria
You may qualify if:
- Acute STEMI within 12 hours from symptoms onset
- Native coronary disease with a lesion suitable for stenting
- Vessel size in between 2.5-3.75mm
- Patient is willing to provide written informed consent
- Male or female patients between 18-85 years of age
You may not qualify if:
- Significant left main disease
- Killip class IV
- Known allergy to aspirin and or clopidogrel/ticlopidine
- Recent bleeding (\<1month)
- Patient in anticoagulant therapy
- No suitable coronary anatomy for OCT scan (ostial lesion, very distal or large vessel /\>3.75mm in diameter/)
- Pregnancy
- Severe liver or renal disease (Cr\>2.0)
- Life expectancy \< 1 year
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Cardiology, Masaryk hospital and University of JEP
Ústí nad Labem, 40113, Czechia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pavel Cervinka, MD, PhD
Krajska zdravotni a.s., Masarzk hospital Usti nad Labem
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 27, 2009
First Posted
April 28, 2009
Study Start
May 1, 2009
Primary Completion
January 1, 2011
Study Completion
May 1, 2011
Last Updated
May 1, 2009
Record last verified: 2009-04