Permanent Intracranial Stenting for Acute Ischemic Stroke Related to a Refractory Large Vessel Occlusion

NAActive, not recruitingINTERVENTIONAL
Enrollment

346

Participants

Timeline

Start Date

November 8, 2023

Primary Completion Date

February 1, 2027

Study Completion Date

August 1, 2027

Conditions
Acute Ischemic Stroke
Interventions
DEVICE

Intracranial stenting

"In order to promote the efficacy of the stent to reopen the target vessel, there are two requirments prior stenting: First, balloon angioplasty can be performed at operators' discretion based on angiographic findings. Second, a dual antiplatelet therapy protocol is considered essential to maintain stent patency, and therefore should be introduced before stent implantation whenever possible.~Permanent Intracranial can then be performed according to the standard technique: An autoexpandable intracranial stent (Neuroform Atlas 4x24mm) is deployed though a dedicated microcatheter over the target refractory occlusion The only stent system allowed is the Neuroform Atlas 4x24mm (Stryker Neurovascular) The anti-thrombotic drugs used, their route of administration, the choice of navigation equipment are left to the discretion of the team in charge of the patient. A standardized anti-thrombotic protocol will be proposed as an indication."

OTHER

Optimal medical care, without additional endovascular procedures

"The control group represents the standard therapeutic strategy for refractory vascular occlusions, which consists of stopping the procedure without performing any additional mechanical thrombectomy attempts.~In this group, the procedure will be stopped after randomization and a control seriography will be performed to confirm the persistent nature of the intracranial occlusion.~The patient will benefit from the best medical care available, which may include any medical treatment including a dual anti-platelet therapy if the therapeutic team deems it necessary (Standard medical care may also include (non-exhaustive list):~* Nursing~* Nursing care~* Symptomatic treatments: analgesics for example~* Systematic clinical monitoring and control imaging if necessary~* Rehabilitation if necessary)"

Trial Locations (13)

33000

CHU Bordeaux (Pellegrin Hospital), Bordeaux

34295

CHU Montpellier - Gui de Chauliac, Montpellier

54035

CHRU de Nancy, Nancy

59037

CHU Lille (Roger Salengro Hospital), Lille

75010

Lariboisière Hospital (APHP), Paris

75013

APHP • Assistance Publique des Hôpitaux de Paris, Pitié-Salpêtrière hospital, Paris

80054

CHU Amiens, Amiens

86021

CHU Poitiers, Poitiers

92150

Foch Hospital, Suresnes

94000

Henri-Mondor Hospital (APHP), Créteil

94010

Henri-Mondor Hospital (APHP), Créteil

94270

Bicêtre Hospital (AP-HP), Le Kremlin-Bicêtre

Bicêtre Hospital (APHP), Le Kremlin-Bicêtre

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT06071091 - Permanent Intracranial Stenting for Acute Ischemic Stroke Related to a Refractory Large Vessel Occlusion | Biotech Hunter | Biotech Hunter