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

Acute Stroke Clinical Trial

— REPAIR-FC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03451903
• Other study ID #: P/2017/348
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Acute Stroke
• Cerebral Infarction
• Infarction
• Stroke

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.