Ultrasound Guided Insertion of Sheath Before Angiography or Angioplasty

NCT ID: NCT03060460

Last Updated: 2019-04-04

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-26

Study Completion Date

2018-12-31

Brief Summary

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The study evaluates whether routine use of ultrasound for sheath insertion during radial or femoral angiography or angioplasty has any impact on: number of punctures, patient discomfort, procedural length, successfull procedure or ideal vessel puncture.

Detailed Description

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A randomised study with an historical control group.

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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Radial Angioplasty Angiography Ultrasound Randomized

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

historical control cohort (Group A) and then a randomized prospective study (Group B and C).
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Ultrasound arm - Randomized group

Ultrasound guided sheath insertion

Group Type EXPERIMENTAL

Ultrasound guided sheath insertion

Intervention Type DIAGNOSTIC_TEST

ultrasound is used routinely for sheath insertion

Conventional arm - Randomized group

Conventional arm during randomized phase

Group Type NO_INTERVENTION

No interventions assigned to this group

Historical control group

Conventional arm, non-randomization phase

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ultrasound guided sheath insertion

ultrasound is used routinely for sheath insertion

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* All patients scheduled for angiography or angioplasty in whom both radial and femoral access is possible

Exclusion Criteria

* Abnormal pulse oxymetry test
* If severe lower-extremity calcification is known to exclude femoral access
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Christian Juhl Terkelsen

OTHER

Sponsor Role lead

Responsible Party

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Christian Juhl Terkelsen

Associate professor

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status

Countries

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Denmark

Other Identifiers

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ACCESS-II

Identifier Type: -

Identifier Source: org_study_id

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