Ultrasound Guided Insertion of Sheath Before Angiography or Angioplasty
NCT ID: NCT03060460
Last Updated: 2019-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
80 participants
INTERVENTIONAL
2017-04-26
2018-12-31
Brief Summary
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Detailed Description
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Initially data on prespecified endpoints are collected for an historical control group of 200 patients (100 radial and 100 femoral procedures). Hereafter 400 patients are randomized to ultrasound guided or conventional sheath insertion (200 radial and 200 femoral procedures).
Only high-volume physicians who have passed a ultrasound course are allowed to include patients.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
NONE
Study Groups
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Ultrasound arm - Randomized group
Ultrasound guided sheath insertion
Ultrasound guided sheath insertion
ultrasound is used routinely for sheath insertion
Conventional arm - Randomized group
Conventional arm during randomized phase
No interventions assigned to this group
Historical control group
Conventional arm, non-randomization phase
No interventions assigned to this group
Interventions
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Ultrasound guided sheath insertion
ultrasound is used routinely for sheath insertion
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* If severe lower-extremity calcification is known to exclude femoral access
18 Years
100 Years
ALL
No
Sponsors
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Christian Juhl Terkelsen
OTHER
Responsible Party
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Christian Juhl Terkelsen
Associate professor
Principal Investigators
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erik sloth, professor
Role: STUDY_CHAIR
Department of anaestesiology, Aarhus University Hospital, DK-8200 Aarhus N
Locations
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Department of cardiology, Aarhus University Hospital in Skejby
Aarhus, , Denmark
Countries
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Other Identifiers
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ACCESS-II
Identifier Type: -
Identifier Source: org_study_id
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