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

NCT06071091 | Active Not Recruiting

• 2 other identifiers: APHP2100912022-A00570-43
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 13

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 cases and, therefore, is associated with a very poor prognosis. These refractory occlusions frequently occur when an underlying intracranial atherosclerotic disease is present. Thus, one of the most promising rescue technique consists of placing a permanent intracranial stent, under dual antiplatelet therapy over the target refractory occlusion. This strategy is well studied in coronary occlusions where the atheroscotic mechanism is highly prevalent. However, as the ischemiated brain is at much higher risk of hemorrhagic complications, such strategy entails a greater risk. This raises the question of whether such risk is worth the reward of obtaining reperfusion. The investigators designed this randomized study in order to evaluate whether a strategy combining rescue pemanent intracranial stenting with the best medical treatment is superior to the best medical treatment alone in acute refractory large vessel occlusions.

Conditions

Acute Ischemic Stroke

Keywords

Brain; Intracranial; Ischemia; Stroke; Mechanical Thrombectomy; Intracranial Occlusion; Refractory Occlusion; Interventional; Angioplasty; Stenting

Outcome Measures

Primary Outcomes (1)

• Rate of independent patients

  Rate of independent patients at 3 months, defined as a modified Rankin Scale (mRS) 0-2, evaluated by a trained health professional, blinded to the randomization arm. Min=0 ; Max=6 (lower is better)

  3 months

Secondary Outcomes (24)

• Mortality

  6 months

• Excellent functional outcome

  3 months

• modified Rankin Scale (mRS)

  3 months

• Successful reperfusion

  End of procedure (up to 4 hours)

• Excellent reperfusion

  End of procedure (up to 4 hours)

Study Arms (2)

Intracranial stenting

EXPERIMENTAL

Rescue Intracranial Stenting + best medical treatment

Device: Intracranial stenting

Best medical management alone

ACTIVE COMPARATOR

Best medical treatment with no additional thrombectomy passes

Other: Optimal medical care, without additional endovascular procedures

Interventions

Intracranial stenting DEVICE

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.

Intracranial stenting

Optimal medical care, without additional endovascular procedures OTHER

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)

Best medical management alone

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Proximal intracranial vascular occlusion not confirmed on angiography
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (13)

CHU Amiens

Amiens, 80054, France

Location

CHU Bordeaux (Pellegrin Hospital)

Bordeaux, 33000, France

Location

Henri-Mondor Hospital (APHP)

Créteil, 94000, France

Location

Henri-Mondor Hospital (APHP)

Créteil, 94010, France

Location

Bicêtre Hospital (AP-HP)

Le Kremlin-Bicêtre, 94270, France

Location

Bicêtre Hospital (APHP)

Le Kremlin-Bicêtre, 94270, France

Location

CHU Lille (Roger Salengro Hospital)

Lille, 59037, France

Location

CHU Montpellier - Gui de Chauliac

Montpellier, 34295, France

Location

CHRU de Nancy

Nancy, 54035, France

Location

Lariboisière Hospital (APHP)

Paris, 75010, France

Location

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

Paris, 75013, France

Location

CHU Poitiers

Poitiers, 86021, France

Location

Foch Hospital

Suresnes, 92150, France

Location

Related Publications (1)

• Premat K, Dechartres A, Baptiste A, Guedon A, Mazighi M, Spelle L, Denier C, Tuilier T, Hosseini H, Lapergue B, Di Maria F, Bricout N, Henon H, Gory B, Richard S, Chivot C, Courselle A, Velasco S, Lamy M, Costalat V, Arquizan C, Marnat G, Sibon I, Lenck S, Shotar E, Allard J, Sourour N, Degos V, Alamowitch S, Clarencon F. Comparison of rescue intracranial stenting versus best medical treatment alone in acute refractory large vessel occlusion: study protocol for the PISTAR multicenter randomized trial. J Neurointerv Surg. 2025 Mar 17;17(4):360-367. doi: 10.1136/jnis-2024-021502.

  PMID: 38538057 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Ischemia; Stroke; Bites and Stings

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Kevin PREMAT, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: October 6, 2023
• Study Start: November 8, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

FR (13)