NCT03451903

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 2, 2018

Completed
Last Updated

March 29, 2018

Status Verified

February 1, 2018

Enrollment Period

2 years

First QC Date

February 26, 2018

Last Update Submit

March 28, 2018

Conditions

Keywords

strokethrombectomyprocedure timerevascularisationthrombolytic therapy

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Mechanical thrombectomy group

Patients with acute stroke treated by mechanical thrombectomy.

Procedure: Mechanical thrombectomy

Combined procedure group

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

Drug: ActilyseProcedure: Mechanical thrombectomy

Interventions

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

Also known as: rtPA
Combined procedure group

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

Combined procedure groupMechanical thrombectomy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBiological Factors

Study Officials

  • Louise Bonnet, MD

    J Minjoz Besancon university Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2018

First Posted

March 2, 2018

Study Start

January 1, 2015

Primary Completion

December 31, 2016

Study Completion

February 1, 2018

Last Updated

March 29, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share