Which Factors Influence the Duration and the Success of Mechanical Thrombectomy During the Acute Phase of Cerebral Infarction? (REPAIR-FC)

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.

Study Overview

• Status: Completed
• Conditions: Acute Stroke
• Intervention / Treatment: Procedure: Mechanical thrombectomy; Drug: Actilyse

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 Type: Observational
• Enrollment (Actual): 106

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who had undergone an arteriography for cerebral infarction prior to mechanical thrombectomy at CHRU Besançon. Data are prospectively collected in the Franche-Comté Stroke Registry.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mechanical thrombectomy group; Patients with acute stroke treated by mechanical thrombectomy.	Procedure: Mechanical thrombectomy; 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.	Procedure: Mechanical thrombectomy; Mechanical thrombectomy is an endovascular procedure by which an arterial clot is retrieved, in order to reperfuse the brain.; Drug: Actilyse; Actilyse is the intra-venous agent used for intra-venous thrombolysis in the acute phase of cerebral infarction.; Other Names: rtPA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Louise Bonnet, MD, J Minjoz Besancon university Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2015
• Primary Completion (ACTUAL): December 31, 2016
• Study Completion (ACTUAL): February 1, 2018

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: March 1, 2018
• First Posted (ACTUAL): March 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 28, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: stroke; thrombolytic therapy; thrombectomy; revascularisation; procedure time
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Brain Infarction; Infarction; Stroke; Cerebral Infarction; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Tissue Plasminogen Activator
• Other Study ID Numbers: P/2017/348

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No