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Boston Scientific COMET Wire Validation Study (COMET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02578381
Recruitment Status : Completed
First Posted : October 19, 2015
Last Update Posted : May 17, 2017
Sponsor:
Collaborators:
Liverpool Heart and Chest Hospital NHS Foundation Trust
Boston Scientific Corporation
Information provided by (Responsible Party):
University Hospital Southampton NHS Foundation Trust

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Stable Angina Device: Boston Scientific Pressure Wire Device: Validation of Boston Scientific pressure wire Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Boston Scientific COMET Wire Validation Study
Actual Study Start Date : March 16, 2016
Actual Primary Completion Date : November 14, 2016
Actual Study Completion Date : November 14, 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: Boston Scientific PW versus St Jude PW
Performance of Boston Scientific PW vs St Jude PW
 Device: Boston Scientific Pressure Wire
St Jude Medical Pressure Wire

Device: Validation of Boston Scientific pressure wire
Experimental: Boston Sci PW vs Boston Sci PW
Boston Sci PW vs Boston Sci PW
 Device: Boston Scientific Pressure Wire
St Jude Medical Pressure Wire

Device: Validation of Boston Scientific pressure wire
Active Comparator: St Jude PW versus St Jude PW
Performance of St Jude PW vs St Jude PW
 Device: Validation of Boston Scientific pressure wire


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • >18yrs age
  • Written informed consent
  • Patients scheduled for diagnostic angiography (and/or "standby" angiography)
  • Clinical requirement for pressure wire assessment

Exclusion Criteria

  • STEMI presentation
  • Aorto-ostial disease
  • Pregnancy
  • CABG
  • Contraindication to adenosine
  • Creatinine >180umol/L
  • Life threatening co-morbidity
  • Severe valve disease
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02578381


Locations
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United Kingdom
Liverpool Heart & Chest NHS Foundation Trust
Liverpool, Merseyside, United Kingdom, L14 3PE
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust
Liverpool Heart and Chest Hospital NHS Foundation Trust
Boston Scientific Corporation
Investigators
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Principal Investigator: Nick Curzen, BM(Hons) PhD University Hospital Southampton NHS Foundation Trust
More Information
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Responsible Party: University Hospital Southampton NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02578381    
Other Study ID Numbers: COMET
First Posted: October 19, 2015    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital Southampton NHS Foundation Trust:
pressure wire
coronary angiogram
validation
Additional relevant MeSH terms:
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Angina, Stable
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
 Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations