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

NCT ID: NCT03451903

Last Updated: 2018-03-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 106 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2018-02-01

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.

Conditions

Acute Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Mechanical thrombectomy group

Patients with acute stroke treated by mechanical thrombectomy.

Mechanical thrombectomy

Intervention Type: PROCEDURE

Mechanical thrombectomy is an endovascular procedure by which an arterial clot is retrieved, in order to reperfuse the brain.

Combined procedure group

Patients with acute stroke treated by intravenous thrombolysis (with actilyse) and mechanical thrombectomy.

Actilyse

Intervention Type: DRUG

Actilyse is the intra-venous agent used for intra-venous thrombolysis in the acute phase of cerebral infarction.

Mechanical thrombectomy

Intervention Type: PROCEDURE

Mechanical thrombectomy is an endovascular procedure by which an arterial clot is retrieved, in order to reperfuse the brain.

Interventions

Actilyse

Actilyse is the intra-venous agent used for intra-venous thrombolysis in the acute phase of cerebral infarction.

Intervention Type: DRUG

Mechanical thrombectomy

Mechanical thrombectomy is an endovascular procedure by which an arterial clot is retrieved, in order to reperfuse the brain.

Intervention Type: PROCEDURE

Other Intervention Names

rtPA

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Louise Bonnet, MD

Role: PRINCIPAL_INVESTIGATOR

J Minjoz Besancon university Hospital

Other Identifiers

P/2017/348

Identifier Type: -

Identifier Source: org_study_id