Neurothrombectomy France

Cerebral Artery Occlusion Clinical Trial

— NTF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02880579
• Other study ID #: RC11_0097
• Status: Completed
• Phase: N/A
• First received: August 5, 2016
• Last updated: August 22, 2016
• Start date: May 2013
• Est. completion date: March 2015

Study information

• Verified date: August 2016
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Cerebral Artery Occlusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical score for handicap (mRS)		at 3 months	No
Secondary	hemorrhagic complications on postoperative imaging		baseline	No
Secondary	hemorrhagic complications on postoperative imaging		at 1 day	No
Secondary	physiological parameter : age	Factors of good clinical prognosis	baseline	No
Secondary	presence of coronary artery disease	Factors of good clinical prognosis	baseline	No
Secondary	presence of arterial hypertension	Factors of good clinical prognosis	baseline	No
Secondary	presence of diabetes	Factors of good clinical prognosis	baseline	No
Secondary	presence of hypercholesterolemia	Factors of good clinical prognosis	baseline	No
Secondary	presence of intracranial stenosis	Factors of good clinical prognosis	baseline	No
Secondary	presence of occlusive arterial disease	Factors of good clinical prognosis	baseline	No
Secondary	presence of haematological disorders	Factors of good clinical prognosis	baseline	No
Secondary	presence of neoplasia	Factors of good clinical prognosis	baseline	No
Secondary	NIHSS score	Factors of good clinical prognosis	baseline	No
Secondary	ASPECTS score	Factors of good clinical prognosis	baseline	No
Secondary	MRI imaging of stroke	Factors of good clinical prognosis	baseline	No
Secondary	unblocking rate based on the score TICI		at 3 months	No
Secondary	NIHSS evaluation		at 24h	No
Secondary	Influence of collaterality score on the NIHSS		at 24h	No
Secondary	Influence ASPECTS score on the NIHSS		at 24h	No
Secondary	Influence ASPECTS score on the NIHSS		at 3months	No
Secondary	influence of anesthesia on the NIHSS		at 24h	No
Secondary	hemorrhagic complications		at 24h	No
Secondary	Influence of hemorrhagic complications on NIHSS		at 24h	No
Secondary	Influence of hemorrhagic complications on NIHSS		at 3 months	No