NCT02216565

Brief Summary

This trial aims at comparing two strategies currently used to address acute ischemic stroke of the middle cerebral artery : medical treatment without endovascular treatment on the one hand, and medical treatment plus endovascular treatment on the other hand. The efficiency of the strategies will be assessed in terms of early neurological clinical recovery. The study will focus on three particular situations : (1) tandem internal carotid and middle cerebral artery occlusion, (2) situations where patient cannot benefit from fibrinolysis because of high risk of haemorrhage, (3) situations where fibrinolysis is not recommended because of a delay superior to 4.5 hours. The hypothesis to be tested is that medical approach plus endovascular treatment is superior to medical treatment alone

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2017

Completed
Last Updated

December 5, 2017

Status Verified

December 1, 2017

Enrollment Period

9 months

First QC Date

August 13, 2014

Last Update Submit

December 4, 2017

Conditions

Stroke, Acute

Keywords

StrokeEndovascular treatmentTandem carotid occlusionsFibrinolysis

Outcome Measures

Primary Outcomes (1)

  • Improvement in NIHSS score after 24h

    Percentage of improvement in the National Institute of Health Stroke Score (NIHSS) between baseline (t0) and h24 (t1) calculated as follow : \[NIHSS(t0) - NIHSS(t1)\] / NIHSS(t0)

    24 hours

Secondary Outcomes (4)

  • Improvement in NIHSS score after 7 days

    7 days

  • Functional recovery after 3 months

    3 months

  • Fatality within 7 days

    7 days

  • Fatality within 3 months

    3 months

Study Arms (2)

Medical treatment

OTHER

Conventional medical non-interventional treatment

Other: Hospitalization in specialized neuro-vascular unitDrug: Alteplase if patient is eligibleOther: Supportive care

Endovascular treatment

OTHER

Conventional medical treatment plus endovascular treatment

Other: Hospitalization in specialized neuro-vascular unitDrug: Alteplase if patient is eligibleOther: Supportive careProcedure: Endovascular treatment

Interventions

Hospitalization in specialized neuro-vascular unitOTHER
Endovascular treatmentMedical treatment
Alteplase if patient is eligibleDRUG

Alteplase intravenous thrombolysis performed if patient is eligible (if not contraindicated)

Endovascular treatmentMedical treatment
Supportive careOTHER

Drugs, procedures and techniques aimed at preventing/managing complications or aggravation of the patient's neurological condition

Endovascular treatmentMedical treatment
Endovascular treatmentPROCEDURE

Recanalization treatment (thrombectomy / intraarterial thrombolysis)

Endovascular treatment

Eligibility Criteria

Age18 Years - 82 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Radiologically proven acute proximal occlusion of middle cerebral artery
  • AND one of the three following :
  • tandem internal carotid / middle cerebral artery occlusion
  • intravenous thrombolysis contraindicated because of high risk of haemorrhage
  • intravenous thrombolysis not possible because of delay \> 4.5 hours

You may not qualify if:

  • Impossibility to perform endovascular recanalization within 6h
  • Clinically minor stroke (NIHSS score below 5 at baseline)
  • Extended cerebral infarction
  • Severe comorbidity
  • Life expectancy below 3 months before stroke
  • Pregnancy or breastfeeding
  • modified Rankin Score superior to 2 before stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hopital Henri Mondor

Créteil, 94010, France

Location

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

Hopital Foch

Suresnes, 92151, France

Location

MeSH Terms

Conditions

Stroke

Interventions

HospitalizationPalliative Care

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Marc-Antoine Labeyrie, MD

    Hopital Lariboisiere, Paris

    PRINCIPAL INVESTIGATOR

  • Michel Piotin, MD

    Fondation Ophtalmologique Adolphe de Rothschild, Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2014

First Posted

August 15, 2014

Study Start

December 1, 2014

Primary Completion

August 31, 2015

Study Completion

August 24, 2017

Last Updated

December 5, 2017

Record last verified: 2017-12

Locations

FR(3)