Neurothrombectomy France

NCT02880579 | Completed

• 1 other identifier: RC11_0097
• Study Type: observational
• Target: 230
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Cerebral Artery Occlusion

Outcome Measures

Primary Outcomes (1)

• clinical score for handicap (mRS)

  at 3 months

Secondary Outcomes (23)

• hemorrhagic complications on postoperative imaging

  baseline

• hemorrhagic complications on postoperative imaging

  at 1 day

• physiological parameter : age

  baseline

• presence of coronary artery disease

  baseline

• presence of arterial hypertension

  baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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) .

You may qualify if:

• 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.

You may not qualify if:

• 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)
• Refusal to participate in the study

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Officials

• Hubert DESAL, PU-PH

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: August 26, 2016
• Study Start: May 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: August 26, 2016

Record last verified: 2016-08