Which Factors Influence the Duration and the Success of Mechanical Thrombectomy During the Acute Phase of Cerebral Infarction?

Completed

• Conditions: Acute Stroke
• Interventions: Procedure: Mechanical thrombectomy; Drug: Actilyse

• Registration Number: NCT03451903
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2016-12-31
• Status Verified: 2018-02
• Study Completion: 2018-02-01
• Study First Submitted: 2018-02-26
• Study First Submitted QC: 2018-03-01
• Study First Posted: 2018-03-02
• Last Update Submitted: 2018-03-28
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mechanical thrombectomy group	Mechanical thrombectomy	Patients with acute stroke treated by mechanical thrombectomy.
Combined procedure group	Actilyse	Patients with acute stroke treated by intravenous thrombolysis (with actilyse) and mechanical thrombectomy.
Combined procedure group	Mechanical thrombectomy	Patients with acute stroke treated by intravenous thrombolysis (with actilyse) and mechanical thrombectomy.

Primary Outcome Measures

Name	Time	Method
Duration of the procedure	From the beginning of mechanical thrombectomy to the end 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.