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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03451903
Other study ID # P/2017/348
Secondary ID
Status Completed
Phase
First received February 26, 2018
Last updated March 28, 2018
Start date January 1, 2015
Est. completion date February 1, 2018

Study information

Verified date February 2018
Source Centre Hospitalier Universitaire de Besancon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to identify factors influencing the time span and success of reperfusion after a mechanical thrombectomy in the acute phase of cerebral infarction, and in particular the effect of intra-venous thrombolysis.


Description:

Mechanical thrombectomy (MT), associated with standard IV thrombolysis (IVT) treatment, is effective during the acute phase of cerebral infarction with proximal occlusion of the anterior circulation in reducing disability at three months. MT-only treatment has only been assessed retrospectively in subgroups of controlled studies, with a significant difference in favour of the treatment. These results have led to a discussion about the benefits of MT without IVT in cases of proximal occlusion or carotid terminus occlusion. Recent data are in favour of a better prognosis for patients benefiting from a combined procedure. The impact of IVT on the implementation of MT is widely disputed, in particular the speed of execution, which could be enhanced by IVT. The factors influencing the time span and success of reperfusion after an MT are still not well-known, IVT in particular. The investigators have made the assumption that IVT could have an effect on the success of MT by shortening the duration of the procedure and increasing the likelihood of satisfactory revascularisation.

The investigators carried out a retrospective study based on data gathered prospectively by the Franche-Comté Stroke Registry. The investigators also considered other factors which could have affected the duration of the procedure or the rate of satisfactory revascularisation, including location of infarct, thrombus size and stroke aetiology.

Hypothesis: the investigators have made the assumption that IVT could have an effect on the success of MT by shortening the duration of the procedure and increasing the likelihood of satisfactory revascularisation.


Recruitment information / eligibility

Status Completed
Enrollment 106
Est. completion date February 1, 2018
Est. primary completion date December 31, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- acute phase of cerebral infarction

- all patients who had undergone an arteriography for cerebral infarction prior to mechanical thrombectomy at CHRU Besançon

- from 1st January 2015 to 31st December 2016

Exclusion Criteria:

- Patients whose procedures were interrupted (puncture failure, catheterisation of the common or internal carotid artery failure)

- Patients whose arteries were recanalised during the diagnostic arteriography

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Actilyse
Actilyse is the intra-venous agent used for intra-venous thrombolysis in the acute phase of cerebral infarction.
Procedure:
Mechanical thrombectomy
Mechanical thrombectomy is an endovascular procedure by which an arterial clot is retrieved, in order to reperfuse the brain.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Outcome

Type Measure Description Time frame Safety issue
Primary Duration of the procedure It is the period of time between when the artery is punctured and when the first image from the first cerebral angiographic test is acquired after revascularisation, which is used to calculate the rate of revascularisation. From the beginning of mechanical thrombectomy to the end of the procedure.
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