## Protocol Section
### Identification Module
**NCT ID:** NCT02880579

**Acronym:** NTF

**Brief Title:** Neurothrombectomy France

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

#### Organization Study ID Info
**ID:** RC11_0097
#### Organization
**Class:** OTHER
**Full Name:** Nantes University Hospital
### Status Module
#### Completion Date
**Date:** 2015-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-08-26

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-08-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-03

**Type:** ACTUAL

#### Start Date
**Date:** 2013-05

**Status Verified Date:** 2016-08

#### Study First Post Date
**Date:** 2016-08-26
**Type:** ESTIMATED
**Study First Submit Date:** 2016-08-05
**Study First Submit QC Date:** 2016-08-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Nantes University Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Cerebral Artery Occlusion

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 230

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Measure:** clinical score for handicap (mRS)

**Time Frame:** at 3 months

#### Secondary Outcomes

**Measure:** hemorrhagic complications on postoperative imaging

**Time Frame:** baseline

**Measure:** hemorrhagic complications on postoperative imaging

**Time Frame:** at 1 day

**Description:** Factors of good clinical prognosis

**Measure:** physiological parameter : age

**Time Frame:** baseline

**Description:** Factors of good clinical prognosis

**Measure:** presence of coronary artery disease

**Time Frame:** baseline

**Description:** Factors of good clinical prognosis

**Measure:** presence of arterial hypertension

**Time Frame:** baseline

**Description:** Factors of good clinical prognosis

**Measure:** presence of diabetes

**Time Frame:** baseline

**Description:** Factors of good clinical prognosis

**Measure:** presence of hypercholesterolemia

**Time Frame:** baseline

**Description:** Factors of good clinical prognosis

**Measure:** presence of intracranial stenosis

**Time Frame:** baseline

**Description:** Factors of good clinical prognosis

**Measure:** presence of occlusive arterial disease

**Time Frame:** baseline

**Description:** Factors of good clinical prognosis

**Measure:** presence of haematological disorders

**Time Frame:** baseline

**Description:** Factors of good clinical prognosis

**Measure:** presence of neoplasia

**Time Frame:** baseline

**Description:** Factors of good clinical prognosis

**Measure:** NIHSS score

**Time Frame:** baseline

**Description:** Factors of good clinical prognosis

**Measure:** ASPECTS score

**Time Frame:** baseline

**Description:** Factors of good clinical prognosis

**Measure:** MRI imaging of stroke

**Time Frame:** baseline

**Measure:** unblocking rate based on the score TICI

**Time Frame:** at 3 months

**Measure:** NIHSS evaluation

**Time Frame:** at 24h

**Measure:** Influence of collaterality score on the NIHSS

**Time Frame:** at 24h

**Measure:** Influence ASPECTS score on the NIHSS

**Time Frame:** at 24h

**Measure:** Influence ASPECTS score on the NIHSS

**Time Frame:** at 3months

**Measure:** influence of anesthesia on the NIHSS

**Time Frame:** at 24h

**Measure:** hemorrhagic complications

**Time Frame:** at 24h

**Measure:** Influence of hemorrhagic complications on NIHSS

**Time Frame:** at 24h

**Measure:** Influence of hemorrhagic complications on NIHSS

**Time Frame:** at 3 months

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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) .

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Nantes University Hospital

**Name:** Hubert DESAL, PU-PH

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M22306

- Name: Stroke

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: HIGH

- As Found: Artery Occlusion

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001157

- Term: Arterial Occlusive Diseases

### Misc Info Module

- Version Holder: 2024-05-24
