Coronary Artery DiseasePhase 4APPOSENCT01776567
Apposition Assessed Using Optical Coherence Tomography of Chromium Stents Eluting Everolimus From Cobalt Versus Platinum Alloy Platforms
A Phase 4 study testing Everolimus eluting stents in people with Coronary Artery Disease, run by Northern Hospital, Australia at 4 sites in Australia.
Trial summary
The purpose of the trial is to directly compare the Cobalt Chromium platform everolimus-eluting stent, Xience Prime™, with the Platinum Chromium platform everolimus-eluting stent, Promus Element™, in relation to stent scaffolding shape, position with the heart blood vessel and extent of tissue coverage (at 6 months)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Everolimus eluting stents
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesAustralia
- Study dates
- Jul 2012to Jun 2015
- 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 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 4.25 mm which can be covered with one or multiple stents
- No limitation to the number of treated lesions or number of vessels according to the randomization group
- De-novo native coronary disease with complex lesions involving: Bifurcations, chronic occlusions > 3 months, lesions > 20mm in length or moderately/heavily calcified lesions of any length
Who cannot join
- Known intolerance to aspirin, clopidogrel, heparin, cobalt chromium, platinum chromium, everolimus, contrast material
- Acute ST-segment elevation myocardial infarction
- Type A lesion including vessel angulation <45 degrees
- Bypass graft
- Inability to provide informed consent
- Pregnancy
Show all 9Show fewer
- 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
4 sites in 1 country.
Australia4 sites, 4 recruiting
- Not yet recruiting
The Prince Charles Hospital
Brisbane, Queensland
Darren Walters
Darren Walters
- Not yet recruiting
Concord Repatriation Hospital
Concord, New South Wales
Harry Lowe
Harry Lowe
- Recruiting
Northern Hospital
Epping, Victoria, 3076
Rita Wong, rita.wong@nh.org.au
Peter Barlis, MBBS PHD FRACP
- Not yet recruiting
St Vincent's Hospital
Melbourne, Victoria, 3065
Robert Whitbourn
Robert Whitbourn
About this study
Official title: Apposition Assessed Using Optical Coherence Tomography of Chromium Stents Eluting Everolimus From Cobalt Versus Platinum Alloy Platforms.
The purpose of the trial is to directly compare the Cobalt Chromium platform everolimus-eluting stent, Xience Prime™, with the Platinum Chromium platform everolimus-eluting stent, Promus Element™, in relation to stent scaffolding shape, position with the heart blood vessel and extent of tissue coverage (at 6 months) using optical coherence tomography.
Hypotheses:
- The alloy composition and strut design of a drug-eluting stent has a direct bearing on stent apposition measured using OCT.
- Stent design and alloy composition have a direct influence on radial support and scaffold shrinkage.
- Conditions
- Coronary Artery Disease
- Being tested
- Everolimus eluting stents
- Keywords
- coronary artery disease, stents, optical imaging
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everolimus eluting stentsDevice
| Study group | Role | What they receive |
|---|---|---|
| Cobalt Chromium Everolimus-eluting stent (Xience Prime) | Active comparator | Cobalt Chromium Everolimus-eluting stent (Xience Prime) Receives: Device: Everolimus eluting stents |
| Platinum Chromium Everolimus-eluting stent (Promus Element) | Active comparator | Platinum Chromium Everolimus-eluting stent (Promus Element) Receives: Device: Everolimus eluting stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Percent incomplete stent apposition using OCT of the CoCr-EES versus the PtCr-EES stent inflated to nominal pressure and following optimal post-dilatation. Stent length (mm) at implantation following nominal pressure and following post-dilatation
Measured: Immediately following stent deployment
Secondary outcomes (3)
Percentage of uncovered stent struts
Measured: 6 mths post initial PCI procedure
Mean neointimal tissue thickness (microns)
Measured: 6 months post initial PCI Procedure
Stent length (mm) measured using OCT
Measured: 6 months post initial PCI procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startJul 2012
- Primary completionDec 2014 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Hospital, Australia
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Principal investigator, A/Prof. Peter Barlis, Northern Hospital, Australia
- Investigators
- Peter Barlis, Principal investigator, Northern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776567
- Sponsor's protocol ID
- 01/12
- Acronym
- APPOSE
- Status last verified
- Aug 2014
- First submitted
- 11 Aug 2012
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
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
- Apposition Assessed Using Optical Coherence Tomography of Chromium Stents Eluting Everolimus From Cobalt Versus Platinum Alloy Platforms.
- ClinicalTrials.gov ID
- NCT01776567
- Acronym / sponsor ID
- APPOSE / 01/12
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, stents, optical imaging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Northern Hospital, AustraliaUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- Jul 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 28 Jan 2013 (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 the trial is to directly compare the Cobalt Chromium platform everolimus-eluting stent, Xience Prime™, with the Platinum Chromium platform everolimus-eluting stent, Promus Element™, in relation to stent scaffolding shape, position with the heart blood vessel and extent of tissue coverage (at 6 months) using optical coherence tomography.
Hypotheses:
- The alloy composition and strut design of a drug-eluting stent has a direct bearing on stent apposition measured using OCT.
- Stent design and alloy composition have a direct influence on radial support and scaffold shrinkage.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cobalt Chromium Everolimus-eluting stent (Xience Prime) | Active comparator | Device: Everolimus eluting stentsCobalt Chromium Everolimus-eluting stent (Xience Prime) |
| Platinum Chromium Everolimus-eluting stent (Promus Element) | Active comparator | Device: Everolimus eluting stentsPlatinum Chromium Everolimus-eluting stent (Promus Element) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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 4.25 mm which can be covered with one or multiple stents
- No limitation to the number of treated lesions or number of vessels according to the randomization group
- De-novo native coronary disease with complex lesions involving: Bifurcations, chronic occlusions > 3 months, lesions > 20mm in length or moderately/heavily calcified lesions of any length
Key exclusion criteria (9 listed)
- Known intolerance to aspirin, clopidogrel, heparin, cobalt chromium, platinum chromium, everolimus, contrast material
- Acute ST-segment elevation myocardial infarction
- Type A lesion including vessel angulation <45 degrees
- Bypass graft
- Inability to provide informed consent
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 |
|---|---|---|
| Everolimus eluting stents | Device | Cobalt Chromium Everolimus-eluting stent (Xience Prime), Platinum Chromium Everolimus-eluting stent (Promus Element) |
Primary outcome
• Percent incomplete stent apposition using OCT of the CoCr-EES versus the PtCr-EES stent inflated to nominal pressure and following optimal post-dilatation. Stent length (mm) at implantation following nominal pressure and following post-dilatation
Time frame: Immediately following stent deployment
3 secondary outcomes
Percentage of uncovered stent struts
Time frame: 6 mths post initial PCI procedure
Mean neointimal tissue thickness (microns)
Time frame: 6 months post initial PCI Procedure
Stent length (mm) measured using OCT
Time frame: 6 months post initial PCI procedure
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.
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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 principal investigator
Northern Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Everolimus eluting stents in people with Coronary Artery Disease, run by Northern Hospital, Australia at 4 sites 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 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 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 4 sites 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 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 Peter Barlis, MBBS MPH PHD FESC FRACP (+61 3 8405 8554, pbarlis@unimelb.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Percent incomplete stent apposition using OCT of the CoCr-EES versus the PtCr-EES stent inflated to nominal pressure and following optimal post-dilatation. Stent length (mm) at implantation following nominal pressure and following post-dilatation (time frame: Immediately following stent deployment). 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 5 Aug 2014.