NCT02989376

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 12, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

2.7 years

First QC Date

December 8, 2016

Last Update Submit

February 18, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • modified Rankin Scale

    at 90 days after onset

Study Arms (1)

carotid duplex ultrasound

EXPERIMENTAL

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.

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

Interventions

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.

carotid duplex ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kohnan hospital

Sendai, Miyagi, 9828523, Japan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ryo Itabashi, MD

    Kohnan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Department chair of Stroke Neurology

Study Record Dates

First Submitted

December 8, 2016

First Posted

December 12, 2016

Study Start

October 1, 2016

Primary Completion

June 30, 2019

Study Completion

October 30, 2019

Last Updated

February 20, 2020

Record last verified: 2020-02

Locations