Status:
ACTIVE_NOT_RECRUITING
Permanent Intracranial Stenting for Acute Ischemic Stroke Related to a Refractory Large Vessel Occlusion
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Clot extraction failure during mechanical thrombectomy is a major concern in the management of acute ischemic stroke related to large vessel occlusions. Indeed, it can occur in up to 10 to 30% of case...
Detailed Description
These past recent years, mechanichal thrombectomy has become the standard treatment for acute ischemic strokes due to large vessel occlusions. Mechanical thrombectomy failure occurs in about 10 to 30%...
Eligibility Criteria
Inclusion
- Age\>18 years
- Acute ischemic stroke secondary to an occlusion of the internal carotid artery termination OR the 1st or 2nd segment of the middle cerebral artery OR the basilar artery and/or the 4th segment of the vertebral artery radiologically proven (CT Angiography or angio-MRI)
- Patient within the authorised timeframe for a MT, according to the AHA/ASA 2019 grade I recommendations
- Refractory intracranial large vessel occlusion defined as :
- Persistent arterial occlusion (mTICI 0 or I) after a minimum of 3 mechanical thrombectomy passes using direct aspiration or a stent retriever OR Early arterial reocclusion (\<10 minutes) after at least one pass OR Underlying stenosis (estimated between 70 and 99%)
- ASPECT Score for CT or DWI-ASPECTS for MRI or pc(-DWI)- ASPECTS (posterior circulation) ≥ 5
- Independent patient before stroke (mRS 0-2)
- Patient's or her/his trusted relative's consent or emergency procedure consent
Exclusion
- Proximal intracranial vascular occlusion not confirmed on angiography
- Intracranial bleeding \<3 months or intracranial bleeding during TM procedure prior to inclusion
- Contraindication to a dual antiplatelet therapy
- Mechanical thrombectomy procedure requiring carotid or vertebral arterial access by direct puncture
- Proof of significant ischemic lesions in a vascular territory not affected by the occlusion
- Proven allergy to iodinated contrast material
- Patient known for severe renal impairment with creatinine clearance \< 30ml/min
- Pregnant or breastfeeding women
- Tandem occlusion (defined as the association of an intracranial occlusion to a cervical steno-occlusive lesion on the same arterial axis that needs additional endovascular manœuvers for the cervical lesion)
- Major comorbidities that could hinder the improvement or the follow up of the patient or the benefit of the intervention
- Unaffiliation to the French Social Security system
- Patient under juridic protection
- Patient participating in another interventional trial
Key Trial Info
Start Date :
November 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
346 Patients enrolled
Trial Details
Trial ID
NCT06071091
Start Date
November 8 2023
End Date
August 1 2027
Last Update
January 9 2024
Active Locations (13)
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1
CHU Amiens
Amiens, France, 80054
2
CHU Bordeaux (Pellegrin Hospital)
Bordeaux, France, 33000
3
Henri-Mondor Hospital (APHP)
Créteil, France, 94000
4
Henri-Mondor Hospital (APHP)
Créteil, France, 94010