Coronary Heart DiseasePhase 3OPTIMANCT01137019
Optical Coherence Tomography Assessment of Intimal Tissue and Malapposition
A Phase 3 study testing Biolimus-eluting stent and Everolimus-eluting coronary stent in people with Coronary Heart Disease, run by Dr Peter Barlis at 1 site in Australia.
Trial summary
The purpose of this study is to use a high-resolution intracoronary imaging modality, called optical coherence tomography (OCT) to examine two different types of coronary artery stents used to treat patients with coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Biolimus-eluting stent and Everolimus-eluting coronary stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2010to Dec 2014
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation myocardial infarction
- Presence of one or more coronary artery stenosis > 50% in a native coronary artery with a reference diameter ranging from 2.25 to 4.0 mm which can be covered with one or multiple stents
- No limitation to the number of treated lesions, number of vessels or lesion length according to the randomization group
Who cannot join
- Known intolerance to aspirin, clopidogrel, heparin, stainless steel, cobalt chromium, Biolimus, everolimus, contrast material
- Acute ST-segment elevation myocardial infarction
- Bypass graft
- Inability to provide informed consent
- Pregnancy
- Planned surgery within 12 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period
- Left ventricular ejection fraction < 25%
- Serum creatinine > 180mmol/L
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optical Coherence Tomography Assessment of Intimal Tissue and Malapposition: A Randomized Comparison of the Biolimus A9-eluting and Everolimus-eluting Coronary Stents
The purpose of this study is to use a high-resolution intracoronary imaging modality, called optical coherence tomography (OCT) to examine two different types of coronary artery stents used to treat patients with coronary artery disease.
Read the detailed description
The development of coronary stents has significantly improved the safety and efficacy of percutaneous coronary intervention (PCI) compared to balloon angioplasty alone. Nevertheless, restenosis is still encountered in 20 to 40% of coronary lesions after implantation of bare metal stents, inferring frequent repeat revascularization procedures with a negative impact on quality of life and health care expenditures. Drug-eluting stents (DES), with their controlled release of therapeutic agents, have significantly reduced the rate of major adverse cardiac events (MACE) following coronary stent implantation, primarily by a reduction in restenosis and target lesion revascularization.
Optical coherence tomography (OCT) is an optical analogue of intravascular ultrasound (IVUS): it uses an infrared light source (wavelength 1310nm) and measures the backscatter of light in a technique similar to conventional ultrasound. With this technique a resolution up to 10μm in-vivo has been reported, a far better level of resolution compared with IVUS. Optical coherence tomography has been used in vivo and has detected early atherosclerotic plaques previously not visualised by IVUS. Segments with strut malapposition and the presence or thickness of neointimal hyperplasia can also be more accurately assessed with OCT compared with IVUS.
The present study will utilize the imaging capabilities of OCT to assess stent strut malapposition and tissue coverage in two different types of DES. The biolimus-eluting stent eludes biolimus from a biodegradable polylactic acid polymer on the abluminal surface of a stainless steel stent. This stent will be compared in a randomized fashion to the permanent polymer based everolimus-eluting coronary stent made of cobalt chromium alloy.
- Conditions
- Coronary Heart Disease
- Being tested
- Biolimus-eluting stent, Everolimus-eluting coronary stent
- Keywords
- Drug-eluting stents, Tomography, Optical Coherence
- 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-eluting stentDevice
Also called Biomatrix Flex (Biosensors International)
The biolimus-eluting coronary stent contains a stainless steel platform on which an abluminally coated polylactic acid (PLA) biodegradable polymer is placed that eludes biolimus-A9.
Everolimus-eluting coronary stentDevice
Also called Promus (BSC)
The everolimus-eluting coronary stent is a cobalt chromium platform stent with a permanent fluorinated copolymer matrix that eludes everolimus
| Study group | Role | What they receive |
|---|---|---|
| Biolimus-eluting stent | Active comparator | Not described Receives: Device: Biolimus-eluting stent |
| Everolimus-eluting stent | Active comparator | Not described Receives: Device: Everolimus-eluting coronary stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of stent strut malapposition
Apposition will be examined immediately following stent implantation following angiographic optimization of stent deployment
Measured: 0 Days
Rate of stent strut tissue coverage
Subjects will be randomized to follow-up at either one of the time points post stenting (3, 6, 12 or 15 months).
Measured: At follow-up (one of either 3, 6, 12 or 15 months)
Secondary outcomes (1)
Major Adverse Cardiac Events
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Peter Barlis
- Sponsor type
- University, hospital or other
- Collaborators
- Biosensors International
- Responsible party
- Sponsor-investigator, Dr Peter Barlis, Northern Hospital, Australia
- Investigators
- Peter Barlis, MBBS PhD FRACP, Principal investigator, Northern Hospital, Department of Cardiology, Victoria, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01137019
- Sponsor's protocol ID
- OPTIMA A19/10
- Acronym
- OPTIMA
- Status last verified
- Aug 2014
- First submitted
- 2 Jun 2010
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barlis P, Regar E, Serruys PW, Dimopoulos K, van der Giessen WJ, van Geuns RJ, Ferrante G, Wandel S, Windecker S, van Es GA, Eerdmans P, Juni P, di Mario C. An optical coherence tomography study of a biodegradable vs. durable polymer-coated limus-eluting stent: a LEADERS trial sub-study. Eur Heart J. 2010 Jan;31(2):165-76. doi: 10.1093/eurheartj/ehp480. Epub 2009 Nov 4.
PubMed 19889649Barlis P, van Soest G, Serruys PW, Regar E. Intracoronary optical coherence tomography and the evaluation of stents. Expert Rev Med Devices. 2009 Mar;6(2):157-67. doi: 10.1586/17434440.6.2.157.
PubMed 19298163Barlis P, Dimopoulos K, Tanigawa J, Dzielicka E, Ferrante G, Del Furia F, Di Mario C. Quantitative analysis of intracoronary optical coherence tomography measurements of stent strut apposition and tissue coverage. Int J Cardiol. 2010 May 28;141(2):151-6. doi: 10.1016/j.ijcard.2008.11.204. Epub 2009 Jan 19.
PubMed 19155076Tanigawa J, Barlis P, Dimopoulos K, Dalby M, Moore P, Di Mario C. The influence of strut thickness and cell design on immediate apposition of drug-eluting stents assessed by optical coherence tomography. Int J Cardiol. 2009 May 15;134(2):180-8. doi: 10.1016/j.ijcard.2008.05.069. Epub 2008 Sep 4.
PubMed 18775576
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Assessment of Intimal Tissue and Malapposition: A Randomized Comparison of the Biolimus A9-eluting and Everolimus-eluting Coronary Stents
- ClinicalTrials.gov ID
- NCT01137019
- Acronym / sponsor ID
- OPTIMA / OPTIMA A19/10
- Conditions
- Coronary Heart Disease
- Keywords
- Drug-eluting stents, Tomography, Optical Coherence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Dr Peter BarlisUniversity, hospital or other
- Collaborators
- Biosensors International
- Study start
- Oct 2010
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 4 Jun 2010 (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 purpose of this study is to use a high-resolution intracoronary imaging modality, called optical coherence tomography (OCT) to examine two different types of coronary artery stents used to treat patients with coronary artery disease.
Detailed description
The development of coronary stents has significantly improved the safety and efficacy of percutaneous coronary intervention (PCI) compared to balloon angioplasty alone. Nevertheless, restenosis is still encountered in 20 to 40% of coronary lesions after implantation of bare metal stents, inferring frequent repeat revascularization procedures with a negative impact on quality of life and health care expenditures. Drug-eluting stents (DES), with their controlled release of therapeutic agents, have significantly reduced the rate of major adverse cardiac events (MACE) following coronary stent implantation, primarily by a reduction in restenosis and target lesion revascularization.
Optical coherence tomography (OCT) is an optical analogue of intravascular ultrasound (IVUS): it uses an infrared light source (wavelength 1310nm) and measures the backscatter of light in a technique similar to conventional ultrasound. With this technique a resolution up to 10μm in-vivo has been reported, a far better level of resolution compared with IVUS. Optical coherence tomography has been used in vivo and has detected early atherosclerotic plaques previously not visualised by IVUS. Segments with strut malapposition and the presence or thickness of neointimal hyperplasia can also be more accurately assessed with OCT compared with IVUS.
The present study will utilize the imaging capabilities of OCT to assess stent strut malapposition and tissue coverage in two different types of DES. The biolimus-eluting stent eludes biolimus from a biodegradable polylactic acid polymer on the abluminal surface of a stainless steel stent. This stent will be compared in a randomized fashion to the permanent polymer based everolimus-eluting coronary stent made of cobalt chromium alloy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biolimus-eluting stent | Active comparator | Device: Biolimus-eluting stent |
| Everolimus-eluting stent | Active comparator | Device: Everolimus-eluting coronary stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation myocardial infarction
- Presence of one or more coronary artery stenosis > 50% in a native coronary artery with a reference diameter ranging from 2.25 to 4.0 mm which can be covered with one or multiple stents
- No limitation to the number of treated lesions, number of vessels or lesion length according to the randomization group
Key exclusion criteria (8 listed)
- Known intolerance to aspirin, clopidogrel, heparin, stainless steel, cobalt chromium, Biolimus, everolimus, contrast material
- Acute ST-segment elevation myocardial infarction
- Bypass graft
- Inability to provide informed consent
- Pregnancy
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-eluting stentAlso: Biomatrix Flex (Biosensors International)The biolimus-eluting coronary stent contains a stainless steel platform on which an abluminally coated polylactic acid (PLA) biodegradable polymer is placed that eludes biolimus-A9. | Device | Biolimus-eluting stent |
| Everolimus-eluting coronary stentAlso: Promus (BSC)The everolimus-eluting coronary stent is a cobalt chromium platform stent with a permanent fluorinated copolymer matrix that eludes everolimus | Device | Everolimus-eluting stent |
Primary outcome
Rate of stent strut malapposition
Time frame: 0 Days
Apposition will be examined immediately following stent implantation following angiographic optimization of stent deployment
Rate of stent strut tissue coverage
Time frame: At follow-up (one of either 3, 6, 12 or 15 months)
Subjects will be randomized to follow-up at either one of the time points post stenting (3, 6, 12 or 15 months).
1 secondary outcome
Major Adverse Cardiac Events
Time frame: 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
- Background: PubMed 19889649Barlis P, Regar E, Serruys PW, Dimopoulos K, van der Giessen WJ, van Geuns RJ, Ferrante G, Wandel S, Windecker S, van Es GA, Eerdmans P, Juni P, di Mario C. An optical coherence tomography study of a biodegradable vs. durable polymer-coated limus-eluting stent: a LEADERS trial sub-study. Eur Heart J. 2010 Jan;31(2):165-76. doi: 10.1093/eurheartj/ehp480. Epub 2009 Nov 4.
- Background: PubMed 19298163Barlis P, van Soest G, Serruys PW, Regar E. Intracoronary optical coherence tomography and the evaluation of stents. Expert Rev Med Devices. 2009 Mar;6(2):157-67. doi: 10.1586/17434440.6.2.157.
- Background: PubMed 19155076Barlis P, Dimopoulos K, Tanigawa J, Dzielicka E, Ferrante G, Del Furia F, Di Mario C. Quantitative analysis of intracoronary optical coherence tomography measurements of stent strut apposition and tissue coverage. Int J Cardiol. 2010 May 28;141(2):151-6. doi: 10.1016/j.ijcard.2008.11.204. Epub 2009 Jan 19.
- Background: PubMed 18775576Tanigawa J, Barlis P, Dimopoulos K, Dalby M, Moore P, Di Mario C. The influence of strut thickness and cell design on immediate apposition of drug-eluting stents assessed by optical coherence tomography. Int J Cardiol. 2009 May 15;134(2):180-8. doi: 10.1016/j.ijcard.2008.05.069. Epub 2008 Sep 4.
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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.
Peter Barlis, MBBS PhD FRACP principal investigator
Northern Hospital, Department of Cardiology, Victoria, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Biolimus-eluting stent and Everolimus-eluting coronary stent in people with Coronary Heart Disease, run by Dr Peter Barlis at 1 site in Australia.
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 4 inclusion and 8 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 5 Aug 2014. 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 Australia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of stent strut malapposition (time frame: 0 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01137019, which also lists 4 linked publications.
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 5 Aug 2014.