Neurothrombectomy France (NTF)

Evaluation of Clinical Results of Treatment of Cerebral Artery Occlusion by Mechanical Thrombectomy, in the Acute Phase of Stroke

The Ischemic Brain Vascular Accident (CVA) is a major public health issue. An Early and appropriate charging anyone with stroke is essential to reduce mortality, reduce dependency and promote recovery of autonomy. Intravenous fibrinolysis in patients with cerebral infarction (NINDS 1995), is reserved for a small proportion of highly selected patients. It therefore remains a significant therapeutic challenge, especially for patients with against-indications to fibrinolysis or in whom there is no immediate benefit. For twenty years of mechanical devices have been developed to remove, as quickly as possible, the cause of intracranial arterial occlusion and allow restoration of blood flow before brain damage is irreversible.

NTF The protocol is part of the evaluation process of our clinical practices recommended by the National Health Authority (HAS), in the specific context of mechanical thrombectomy performed in French centers of interventional neuroradiology working with neurovascular units (A V).

Study Overview

• Status: Completed
• Conditions: Cerebral Artery Occlusion

• Study Type: Observational
• Enrollment (Actual): 230

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • CHU de Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

200 consecutive patients admitted to a stroke unit for cerebral infarction treated by thrombectomy included (with or without fibrinolysis by intra venous) prospectively over a period of 1 year and 3 months followed for clinical neurological assessment (primary endpoint) .

Description

Inclusion Criteria:

• Signature of the information notice by the patient or his legal representative
• Age> 18 years
• Clinical and imaging consistent with ischemic stroke whose symptoms start back within 8h
• Thrombosis (TICI 0 or 1) of the carotid T, M1, M1-M2 bifurcation of the basilar artery occlusion in TANDEM ACI / M1.

Exclusion Criteria:

• Pregnant or lactating women
• Rapid improvement of NIHSS (gain of more than 4 points) between two pre-treatment assessments.
• ASPECT score <7 on the scanner or <5 on the diffusion-weighted imaging (DWI)
• Intracranial hemorrhage on imaging
• Inability of clinical evaluations at 3 months
• extensive lesions of the brain stem (the presence of a complete section of the brainstem hyperintense b1000)
• 0 Refusal to participate in the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
clinical score for handicap (mRS)	at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hemorrhagic complications on postoperative imaging		baseline
hemorrhagic complications on postoperative imaging		at 1 day
physiological parameter : age	Factors of good clinical prognosis	baseline
presence of coronary artery disease	Factors of good clinical prognosis	baseline
presence of arterial hypertension	Factors of good clinical prognosis	baseline
presence of diabetes	Factors of good clinical prognosis	baseline
presence of hypercholesterolemia	Factors of good clinical prognosis	baseline
presence of intracranial stenosis	Factors of good clinical prognosis	baseline
presence of occlusive arterial disease	Factors of good clinical prognosis	baseline
presence of haematological disorders	Factors of good clinical prognosis	baseline
presence of neoplasia	Factors of good clinical prognosis	baseline
NIHSS score	Factors of good clinical prognosis	baseline
ASPECTS score	Factors of good clinical prognosis	baseline
MRI imaging of stroke	Factors of good clinical prognosis	baseline
unblocking rate based on the score TICI		at 3 months
NIHSS evaluation		at 24h
Influence of collaterality score on the NIHSS		at 24h
Influence ASPECTS score on the NIHSS		at 24h
Influence ASPECTS score on the NIHSS		at 3months
influence of anesthesia on the NIHSS		at 24h
hemorrhagic complications		at 24h
Influence of hemorrhagic complications on NIHSS		at 24h
Influence of hemorrhagic complications on NIHSS		at 3 months

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Hubert DESAL, PU-PH, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: August 5, 2016
• First Submitted That Met QC Criteria: August 22, 2016
• First Posted (Estimated): August 26, 2016

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: RC11_0097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No