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Carotid Duplex Ultrasound for Selecting Patients for Endovascular Thrombectomy in Acute Stroke Patients (ECHO-SELECT)

Primary Purpose

Stroke, Acute

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
After detection of occluded vessels by vascular imaging using carotid duplex ultrasound, digital subtraction angiography is immediately performed before acute endovascular treatment.
Sponsored by
Ryo Itabashi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kohnan hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

carotid duplex ultrasound

Arm Description

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.

Outcomes

Primary Outcome Measures

modified Rankin Scale

Secondary Outcome Measures

Full Information

First Posted
December 8, 2016
Last Updated
February 18, 2020
Sponsor
Ryo Itabashi
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1. Study Identification

Unique Protocol Identification Number
NCT02989376
Brief Title
Carotid Duplex Ultrasound for Selecting Patients for Endovascular Thrombectomy in Acute Stroke Patients
Acronym
ECHO-SELECT
Official Title
Emergent Carotid Ultrasound in Hyperacute Cerebral Vessel Occlusion for Selecting Patients to be Treated With Endovascular Clot Retrieval Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ryo Itabashi

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
carotid duplex ultrasound
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
After detection of occluded vessels by vascular imaging using carotid duplex ultrasound, digital subtraction angiography is immediately performed before acute endovascular treatment.
Intervention Description
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.
Primary Outcome Measure Information:
Title
modified Rankin Scale
Time Frame
at 90 days after onset

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryo Itabashi, MD
Organizational Affiliation
Kohnan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kohnan hospital
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
9828523
Country
Japan

12. IPD Sharing Statement

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

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