Boston Scientific COMET Wire Validation Study (COMET)

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

Study Overview

• Status: Completed
• Conditions: Stable Angina
• Intervention / Treatment: Device: Boston Scientific Pressure Wire; Device: Validation of Boston Scientific 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 Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Southampton, United Kingdom, SO16 6YD
    • Southampton General Hospital
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L14 3PE
      • Liverpool Heart & Chest NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Day one

Collaborators and Investigators

• Sponsor: University Hospital Southampton NHS Foundation Trust
• Collaborators: Boston Scientific Corporation; Liverpool Heart and Chest Hospital NHS Foundation Trust
• Investigators: Principal Investigator: Nick Curzen, BM(Hons) PhD, University Hospital Southampton NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2016
• Primary Completion (Actual): November 14, 2016
• Study Completion (Actual): November 14, 2016

Study Registration Dates

• First Submitted: September 29, 2015
• First Submitted That Met QC Criteria: October 14, 2015
• First Posted (Estimate): October 19, 2015

Study Record Updates

• Last Update Posted (Actual): May 17, 2017
• Last Update Submitted That Met QC Criteria: May 16, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: coronary angiogram; validation; pressure wire
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Angina, Stable
• Other Study ID Numbers: COMET

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO