Coronary Heart DiseasePhase 4ROBUSTNCT00888758
Comparison of Biolimus A9 and Everolimus Drug-Eluting Stents in Patients With ST Segment Elevation Myocardial Infarction
A Phase 4 study testing biolimus A9 and everolimus in people with Coronary Heart Disease and Percutaneous Coronary Intervention, run by Masaryk University at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Heart Disease, Percutaneous Coronary Intervention
- What is being tested?
- biolimus A9 and everolimus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteCzechia
- Study dates
- May 2009to May 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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/)
Show all 9Show fewer
- Pregnancy
- Severe liver or renal disease (Cr>2.0)
- Life expectancy < 1 year
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Department of Cardiology, Masaryk hospital and University of JEP
Ústí nad Labem, 40113
Pavel Cervinka, MD,PhD, +420477117886, pavel.cervinka@mnul.cz
Petr Kala, MD,P hD
About this study
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.
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
Read the 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.
- Being tested
- biolimus A9, everolimus
- Keywords
- Stents
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biolimus A9Device
Also called biolimus A9 eluting stent
200 patients with STEMI will be treated using Biomatrix stent.
everolimusDevice
Also called everolimus eluting stent
200 patients with STEMI will be treated with PROMUS DES.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: biolimus A9 |
| 2 | Active comparator | Not described Receives: Device: everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (4)
number of uncovered stent struts
Measured: 2 years
number of malaposed stents struts
Measured: 2 years
in-stent neointimal volume
Measured: 2 years
in-segment assessment of vessel wall response to DES
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionJan 2011 (estimated)
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masaryk University
- Sponsor type
- University, hospital or other
- Investigators
- Pavel Cervinka, MD, PhD, Principal investigator, Krajska zdravotni a.s., Masarzk hospital Usti nad Labem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888758
- Sponsor's protocol ID
- 06042006
- Acronym
- ROBUST
- Status last verified
- Apr 2009
- First submitted
- 27 Apr 2009
- Last updated
- 1 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00888758
- Acronym / sponsor ID
- ROBUST / 06042006
- Keywords
- Stents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Masaryk UniversityUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jan 2011 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 28 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: biolimus A9 |
| 2 | Active comparator | Device: everolimus |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Significant left main disease
- Killip class IV
- Known allergy to aspirin and or clopidogrel/ticlopidine
- Recent bleeding (<1month)
- Patient in anticoagulant therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biolimus A9Also: biolimus A9 eluting stent200 patients with STEMI will be treated using Biomatrix stent. | Device | 1 |
| everolimusAlso: everolimus eluting stent200 patients with STEMI will be treated with PROMUS DES. | Device | 2 |
Primary outcome
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
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pavel Cervinka, MD, PhD principal investigator
Krajska zdravotni a.s., Masarzk hospital Usti nad Labem
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing biolimus A9 and everolimus in people with Coronary Heart Disease and Percutaneous Coronary Intervention, run by Masaryk University at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pavel Cervinka, MD,PhD (+420477117886, pavel.cervinka@mnul.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2009.