Carotid Duplex Ultrasound for Selecting Patients for Endovascular Thrombectomy in Acute Stroke Patients

NCT ID: NCT02989376

Last Updated: 2020-02-20

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

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2019-10-30

Brief Summary

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The aim of this study is to address the usefulness of carotid duplex ultrasound as vascular imaging for selecting acute stroke patients for endovascular thrombectomy.

Detailed Description

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Conditions

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Stroke, Acute

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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carotid duplex ultrasound

Single arm study. After detection of occluded vessels by vascular imaging using carotid duplex ultrasound, digital subtraction angiography is immediately performed before acute endovascular treatment.

Group Type EXPERIMENTAL

After detection of occluded vessels by vascular imaging using carotid duplex ultrasound, digital subtraction angiography is immediately performed before acute endovascular treatment.

Intervention Type PROCEDURE

When the ratio of the end diastolic velocity in the common carotid arteries is greater than 1.4 or the diastolic flow in the internal carotid artery is not detected by vascular imaging using carotid duplex ultrasound, digital subtraction angiography is immediately performed before acute endovascular treatment. If vessel occlusion is not detected by carotid duplex ultrasound, additional vascular imaging including MR angiography or CT angiography is considered.

Interventions

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After detection of occluded vessels by vascular imaging using carotid duplex ultrasound, digital subtraction angiography is immediately performed before acute endovascular treatment.

When the ratio of the end diastolic velocity in the common carotid arteries is greater than 1.4 or the diastolic flow in the internal carotid artery is not detected by vascular imaging using carotid duplex ultrasound, digital subtraction angiography is immediately performed before acute endovascular treatment. If vessel occlusion is not detected by carotid duplex ultrasound, additional vascular imaging including MR angiography or CT angiography is considered.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Endovascular treatment can be initiated within 6 hours of symptom onset.
* ASPECTS of \>=6 is diagnosed by two or more stroke physicians.
* The end diastolic velocity in the common carotid arteries or internal carotid artery is evaluated by carotid duplex ultrasound
* NIHSS score of \>=6.
* Age\>=18 years.
* Written informed consent is obtained.

Exclusion Criteria

* Pre-stroke modified Rankin Scale (mRS) score \>=2.
* Difficulties to evaluate ASPECTS on initial CT.
* Difficulties to groin puncture.
* History of severe allergic reaction to contrast medium.
* End stage renal disease.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ryo Itabashi

OTHER

Sponsor Role lead

Responsible Party

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Ryo Itabashi

Department chair of Stroke Neurology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ryo Itabashi, MD

Role: PRINCIPAL_INVESTIGATOR

Kohnan Hospital

Locations

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Kohnan hospital

Sendai, Miyagi, Japan

Site Status

Countries

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Japan

Other Identifiers

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KohnanSN01

Identifier Type: -

Identifier Source: org_study_id

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