Comparison of Biolimus A9 and Everolimus Drug-Eluting Stents in Patients With ST Segment Elevation Myocardial Infarction (ROBUST)
Primary Purpose
Coronary Heart Disease, Percutaneous Coronary Intervention
Status
Unknown status
Phase
Phase 4
Locations
Czech Republic
Study Type
Interventional
Intervention
biolimus A9
everolimus
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Heart Disease focused on measuring Stents
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Department of Cardiology, Masaryk hospital and University of JEP
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
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
Secondary Outcome Measures
number of uncovered stent struts
number of malaposed stents struts
in-stent neointimal volume
in-segment assessment of vessel wall response to DES
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00888758
Brief Title
Comparison of Biolimus A9 and Everolimus Drug-Eluting Stents in Patients With ST Segment Elevation Myocardial Infarction
Acronym
ROBUST
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 Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
January 2011 (Anticipated)
Study Completion Date
May 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Masaryk University
4. Oversight
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Percutaneous Coronary Intervention
Keywords
Stents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
biolimus A9
Other Intervention Name(s)
biolimus A9 eluting stent
Intervention Description
200 patients with STEMI will be treated using Biomatrix stent.
Intervention Type
Device
Intervention Name(s)
everolimus
Other Intervention Name(s)
everolimus eluting stent
Intervention Description
200 patients with STEMI will be treated with PROMUS DES.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
number of uncovered stent struts
Time Frame
2 years
Title
number of malaposed stents struts
Time Frame
2 years
Title
in-stent neointimal volume
Time Frame
2 years
Title
in-segment assessment of vessel wall response to DES
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pavel Cervinka, MD,PhD
Phone
+420477117886
Email
pavel.cervinka@mnul.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pavel Cervinka, MD, PhD
Organizational Affiliation
Krajska zdravotni a.s., Masarzk hospital Usti nad Labem
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Masaryk hospital and University of JEP
City
Ústí nad Labem
ZIP/Postal Code
40113
Country
Czech Republic
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pavel Cervinka, MD,PhD
Phone
+420477117886
Email
pavel.cervinka@mnul.cz
First Name & Middle Initial & Last Name & Degree
Petr Kala, MD,P hD
First Name & Middle Initial & Last Name & Degree
Ladislav Pesl, MD
12. IPD Sharing Statement
Learn more about this trial
Comparison of Biolimus A9 and Everolimus Drug-Eluting Stents in Patients With ST Segment Elevation Myocardial Infarction
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