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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02989376
Other study ID # KohnanSN01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2016
Est. completion date October 30, 2019

Study information

Verified date February 2020
Source Kohnan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date October 30, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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.

Locations

Country Name City State
Japan Kohnan hospital Sendai Miyagi

Sponsors (1)

Lead Sponsor Collaborator
Ryo Itabashi

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary modified Rankin Scale at 90 days after onset
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