Clinical trial NCT02578381: Boston Scientific COMET Wire Validation Study
Official title: Boston Scientific COMET Wire Validation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stable Angina
Keywords: pressure wire
coronary angiogram
validation
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Liverpool Heart and Chest Hospital NHS Foundation Trust
name: Boston Scientific Corporation
First posted: 2015-10-19
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

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

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.

Eligibility 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

Primary outcomes:
measure: Coronary artery pressure as measured by Boston Scientific Pressure Wire (BSPW)
timeFrame: Day one
measure: Coronary artery pressure as measured by St Jude Medical Pressure Wire (SJPW)
timeFrame: Day one
Secondary outcomes:
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool Heart & Chest NHS Foundation Trust
state: Merseyside
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: University Hospital Southampton NHS Foundation Trust
name: Nick Curzen, BM(Hons) PhD
role: PRINCIPAL_INVESTIGATOR
References: