Boston Scientific COMET Wire Validation Study
COMET
1 other identifier
interventional
106
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2016
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2015
CompletedFirst Posted
Study publicly available on registry
October 19, 2015
CompletedStudy Start
First participant enrolled
March 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 14, 2016
CompletedMay 17, 2017
May 1, 2017
8 months
September 29, 2015
May 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (3)
Boston Scientific PW versus St Jude PW
EXPERIMENTALPerformance of Boston Scientific PW vs St Jude PW
Boston Sci PW vs Boston Sci PW
EXPERIMENTALBoston Sci PW vs Boston Sci PW
St Jude PW versus St Jude PW
ACTIVE COMPARATORPerformance of St Jude PW vs St Jude PW
Interventions
St Jude Medical Pressure Wire
Eligibility Criteria
You may qualify if:
- \>18yrs age
- Written informed consent
- Patients scheduled for diagnostic angiography (and/or "standby" angiography)
- Clinical requirement for pressure wire assessment
You may not qualify if:
- STEMI presentation
- Aorto-ostial disease
- Pregnancy
- CABG
- Contraindication to adenosine
- Creatinine \>180umol/L
- Life threatening co-morbidity
- Severe valve disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Liverpool Heart & Chest NHS Foundation Trust
Liverpool, Merseyside, L14 3PE, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nick Curzen, BM(Hons) PhD
University Hospital Southampton NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2015
First Posted
October 19, 2015
Study Start
March 16, 2016
Primary Completion
November 14, 2016
Study Completion
November 14, 2016
Last Updated
May 17, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share