Stable AnginaCOMETNCT02578381
Boston Scientific COMET Wire Validation Study
A study testing Boston Scientific Pressure Wire and Validation of Boston Scientific pressure wire in people with Stable Angina, run by University Hospital Southampton NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
Summary of Study Aims To assess, in a randomised fashion: 1. performance of Boston Scientific Pressure Wire versus St Jude Pressure Wire 2. performance of Boston Scientific Pressure Wire versus Boston Scientific Pressure Wire 3. performance of St Jude Pressure Wire versus St Jude Pressure Wire Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Angina
- What is being tested?
- Boston Scientific Pressure Wire and Validation of Boston Scientific pressure wire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 16 Mar 2016to 14 Nov 2016
- Phase
- Interventional
- 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
- >18yrs age
- Written informed consent
- Patients scheduled for diagnostic angiography (and/or "standby" angiography)
- Clinical requirement for pressure wire assessment
Who cannot join
- STEMI presentation
- Aorto-ostial disease
- Pregnancy
- CABG
- Contraindication to adenosine
- Creatinine >180umol/L
- Life threatening co-morbidity
- Severe valve disease
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Liverpool Heart & Chest NHS Foundation Trust
Liverpool, Merseyside, L14 3PE
Southampton General Hospital
Southampton, SO16 6YD
About this study
Summary of Study Aims
To assess, in a randomised fashion:
- performance of Boston Scientific Pressure Wire versus St Jude Pressure Wire
- performance of Boston Scientific Pressure Wire versus Boston Scientific Pressure Wire
- performance of St Jude Pressure Wire versus St Jude Pressure Wire
Read the detailed description
Given the following key points of evidence, the optimal management of chest pain patients who come to diagnostic coronary angiography would more often be achieved if there was concomitant data with regard to the presence of patient-specific and lesion-specific ischaemia:
- that it is the presence and extent of reversible myocardial ischaemia (RMI) that dominates over coronary anatomy as a predictor of near term cardiovascular events, as well as symptom relief
- that prognostic benefit after revascularisation is greatest in patients with the largest pre-procedure ischaemic burden
- that intra-coronary pressure wire (PW) data are strongly correlated with subsequent cardiac events despite the binary nature of the test
- that stenting of coronary lesions that are PW negative has a worse outcome than optimal medical therapy (OMT)
- that PW-directed percutaneous coronary intervention (PCI) in multivessel disease is associated with a better clinical outcome than angiogram-directed PCI despite fewer treated lesions and less stents
- that PW-directed PCI improves prognosis compared to OMT
- that mismatch exists in up to 30-40% of lesions encountered at angiography between the visual appearance of the severity of the lesion and whether the lesion is "ischaemic" (and therefore a target for revascularisation) according to PW.
The availability of PW has been shown to have had a substantial effect on overall management of patients undergoing diagnostic coronary angiography (ie when options are still OMT/PCI and coronary artery bypass grafting (CABG) in several observation studies including RIPCORD and the French Registry.
Yet, despite the seemingly persuasive data summarised here, the uptake of PW at the diagnostic stage of the patient pathway is still low. There are, as yet, no suitably powered randomised trials using the PW systematically at the stage of diagnostic angiography and comparing outcome with management based upon angiography alone. This is the gap that will be filled by RIPCORD2.
RIPCORD2 will use the new Boston Scientific Pressure Wire (BSPW), which is currently undergoing first-in-man testing in Chile. The device has, of course, already been internally validated by Boston Scientific engineers and scientists, but the purpose of the COMET study is to provide independent and objective validation of the performance of BSPW using the performance of the St Jude Medical pressure wire (SJPW) as the reference, both using inter-wire and intra-wire measurements. Thus, not only will we assess the reproducibility of the measurements between the 2 wires, but the investigators will also compare reproducibility of measurements from 2 wires of the same manufacturer.
- Conditions
- Stable Angina
- Being tested
- Boston Scientific Pressure Wire, Validation of Boston Scientific pressure wire
- Keywords
- pressure wire, coronary angiogram, validation
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boston Scientific Pressure WireDevice
St Jude Medical Pressure Wire
Validation of Boston Scientific pressure wireDevice
| Study group | Role | What they receive |
|---|---|---|
| Boston Scientific PW versus St Jude PW | Experimental | Performance of Boston Scientific PW vs St Jude PW Receives: Device: Boston Scientific Pressure Wire; Device: Validation of Boston Scientific pressure wire |
| Boston Sci PW vs Boston Sci PW | Experimental | Boston Sci PW vs Boston Sci PW Receives: Device: Boston Scientific Pressure Wire; Device: Validation of Boston Scientific pressure wire |
| St Jude PW versus St Jude PW | Active comparator | Performance of St Jude PW vs St Jude PW Receives: Device: Validation of Boston Scientific pressure wire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary artery pressure as measured by Boston Scientific Pressure Wire (BSPW)
The study will involve the use of two pressure wires simultaneously in a coronary artery.
The three randomisation groups will allow the comparison of pressure measurements between two different wires (BSPW vs SJPW) and will document consistency of readings within the same wire (BSPW vs BSPW or SJPW vs SJPW). Measurements will be undertaken using standard drug protocols. No additional drugs will be necessary for study purposes.
- The first wire allocated at randomisation will be passed to the target measurement position in the artery
- The second wire allocated at randomisation will be passed to exactly the same point in the vessel
- Positioning of the wires will be confirmed by X-rays
- Simultaneous measurements will be taken from the 2 pressure wires
- If there is a narrowing in more than one vessel the process will be repeated for each vessel. Once the measurement has been taken, both wires will be removed.
Measured: Day one
Coronary artery pressure as measured by St Jude Medical Pressure Wire (SJPW)
The study will involve the use of two pressure wires simultaneously in a coronary artery.
The three randomisation groups will allow the comparison of pressure measurements between two different wires (BSPW vs SJPW) and will document consistency of readings within the same wire (BSPW vs BSPW or SJPW vs SJPW). Measurements will be undertaken using standard drug protocols. No additional drugs will be necessary for study purposes.
- The first wire allocated at randomisation will be passed to the target measurement position in the artery
- The second wire allocated at randomisation will be passed to exactly the same point in the vessel
- Positioning of the wires will be confirmed by X-rays
- Simultaneous measurements will be taken from the 2 pressure wires
- If there is a narrowing in more than one vessel the process will be repeated for each vessel. Once the measurement has been taken, both wires will be removed.
Measured: Day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study start16 Mar 2016
- Primary completion14 Nov 2016
- Study completion14 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable AnginaStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Liverpool Heart and Chest Hospital NHS Foundation Trust, Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Nick Curzen, BM(Hons) PhD, Principal investigator, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578381
- Sponsor's protocol ID
- COMET
- Acronym
- COMET
- Status last verified
- May 2017
- First submitted
- 29 Sep 2015
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boston Scientific COMET Wire Validation Study
- ClinicalTrials.gov ID
- NCT02578381
- Acronym / sponsor ID
- COMET / COMET
- Conditions
- Stable Angina
- Keywords
- pressure wire, coronary angiogram, validation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Liverpool Heart and Chest Hospital NHS Foundation Trust, Boston Scientific Corporation
- Study start
- 16 Mar 2016 (actual)
- Primary completion
- 14 Nov 2016 (actual)
- Study completion
- 14 Nov 2016 (actual)
- First posted
- 19 Oct 2015 (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.
Summary of Study Aims
To assess, in a randomised fashion:
- performance of Boston Scientific Pressure Wire versus St Jude Pressure Wire
- performance of Boston Scientific Pressure Wire versus Boston Scientific Pressure Wire
- performance of St Jude Pressure Wire versus St Jude Pressure Wire
Detailed description
Given the following key points of evidence, the optimal management of chest pain patients who come to diagnostic coronary angiography would more often be achieved if there was concomitant data with regard to the presence of patient-specific and lesion-specific ischaemia:
- that it is the presence and extent of reversible myocardial ischaemia (RMI) that dominates over coronary anatomy as a predictor of near term cardiovascular events, as well as symptom relief
- that prognostic benefit after revascularisation is greatest in patients with the largest pre-procedure ischaemic burden
- that intra-coronary pressure wire (PW) data are strongly correlated with subsequent cardiac events despite the binary nature of the test
- that stenting of coronary lesions that are PW negative has a worse outcome than optimal medical therapy (OMT)
- that PW-directed percutaneous coronary intervention (PCI) in multivessel disease is associated with a better clinical outcome than angiogram-directed PCI despite fewer treated lesions and less stents
- that PW-directed PCI improves prognosis compared to OMT
- that mismatch exists in up to 30-40% of lesions encountered at angiography between the visual appearance of the severity of the lesion and whether the lesion is "ischaemic" (and therefore a target for revascularisation) according to PW.
The availability of PW has been shown to have had a substantial effect on overall management of patients undergoing diagnostic coronary angiography (ie when options are still OMT/PCI and coronary artery bypass grafting (CABG) in several observation studies including RIPCORD and the French Registry.
Yet, despite the seemingly persuasive data summarised here, the uptake of PW at the diagnostic stage of the patient pathway is still low. There are, as yet, no suitably powered randomised trials using the PW systematically at the stage of diagnostic angiography and comparing outcome with management based upon angiography alone. This is the gap that will be filled by RIPCORD2.
RIPCORD2 will use the new Boston Scientific Pressure Wire (BSPW), which is currently undergoing first-in-man testing in Chile. The device has, of course, already been internally validated by Boston Scientific engineers and scientists, but the purpose of the COMET study is to provide independent and objective validation of the performance of BSPW using the performance of the St Jude Medical pressure wire (SJPW) as the reference, both using inter-wire and intra-wire measurements. Thus, not only will we assess the reproducibility of the measurements between the 2 wires, but the investigators will also compare reproducibility of measurements from 2 wires of the same manufacturer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Boston Scientific PW versus St Jude PW | Experimental | Device: Boston Scientific Pressure Wire, Device: Validation of Boston Scientific pressure wirePerformance of Boston Scientific PW vs St Jude PW |
| Boston Sci PW vs Boston Sci PW | Experimental | Device: Boston Scientific Pressure Wire, Device: Validation of Boston Scientific pressure wireBoston Sci PW vs Boston Sci PW |
| St Jude PW versus St Jude PW | Active comparator | Device: Validation of Boston Scientific pressure wirePerformance of St Jude PW vs St Jude PW |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >18yrs age
- Written informed consent
- Patients scheduled for diagnostic angiography (and/or "standby" angiography)
- Clinical requirement for pressure wire assessment
Key exclusion criteria (8 listed)
- STEMI presentation
- Aorto-ostial disease
- Pregnancy
- CABG
- Contraindication to adenosine
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 |
|---|---|---|
| Boston Scientific Pressure WireSt Jude Medical Pressure Wire | Device | Boston Sci PW vs Boston Sci PW, Boston Scientific PW versus St Jude PW |
| Validation of Boston Scientific pressure wire | Device | Boston Sci PW vs Boston Sci PW, Boston Scientific PW versus St Jude PW, St Jude PW versus St Jude PW |
Primary outcome
Coronary artery pressure as measured by Boston Scientific Pressure Wire (BSPW)
Time frame: Day one
The study will involve the use of two pressure wires simultaneously in a coronary artery. The three randomisation groups will allow the comparison of pressure measurements between two different wires (BSPW vs SJPW) and will document consistency of readings within the same wire (BSPW vs BSPW or SJPW vs SJPW). Measurements will be undertaken using standard drug protocols. No additional drugs will be necessary for study purposes. * The first wire allocated at randomisation will be passed to the target measurement position in the artery * The second wire allocated at randomisation will be passed to exactly the same point in the vessel * Positioning of the wires will be confirmed by X-rays * Simultaneous measurements will be taken from the 2 pressure wires * If there is a narrowing in more than one vessel the process will be repeated for each vessel. Once the measurement has been taken, both wires will be removed.
Coronary artery pressure as measured by St Jude Medical Pressure Wire (SJPW)
Time frame: Day one
The study will involve the use of two pressure wires simultaneously in a coronary artery. The three randomisation groups will allow the comparison of pressure measurements between two different wires (BSPW vs SJPW) and will document consistency of readings within the same wire (BSPW vs BSPW or SJPW vs SJPW). Measurements will be undertaken using standard drug protocols. No additional drugs will be necessary for study purposes. * The first wire allocated at randomisation will be passed to the target measurement position in the artery * The second wire allocated at randomisation will be passed to exactly the same point in the vessel * Positioning of the wires will be confirmed by X-rays * Simultaneous measurements will be taken from the 2 pressure wires * If there is a narrowing in more than one vessel the process will be repeated for each vessel. Once the measurement has been taken, both wires will be removed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Individual participant dataSharing planned: No
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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.
Nick Curzen, BM(Hons) PhD principal investigator
University Hospital Southampton NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boston Scientific Pressure Wire and Validation of Boston Scientific pressure wire in people with Stable Angina, run by University Hospital Southampton NHS Foundation Trust at 2 sites in United Kingdom.
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: finished, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Coronary artery pressure as measured by Boston Scientific Pressure Wire (BSPW) (time frame: Day one). 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?
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 17 May 2017.