Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT06071091 En recrutement IDF

Titre

Comparison of Permanent Intracranial Stenting Versus no Stenting in Stroke Secondary to Refractory Acute Proximal Vascular Occlusion: a Multicenter Randomized Controlled Trial (PISTAR)

Type

Interventional

Pathologie

Ischémie
Accident vasculaire cérébral

Phase

N/A

Promoteur

Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)

Date de début

novembre 2023

Date de fin

août 2027

Dernière mise à jour

04 mai 2025

Résumé

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.

Détail

Voir le détail 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% of cases with disastrous consequences for these patients. Indeed, reperfusion failures are associated with 30.5% mortality rates and only 21% of all patients are able to achieve functional independence at 3 months. In order to treat these refractory large vessel occlusions many techniques and devices have been developped. Rescue Intracranial Stenting (RIS) is the most studied technique and the most promising one. However, RIS requires strong antithrombotic medications to ensure stent patency, which may increase the risk of hemorrhagic complications. The investigators recently performed a meta-analysis of observational data, that showed that RIS in refractory large vessel occlusions allowed significant improvements in functional outcome at 3 months. The rate of good functional outcome at 3 months went from 21% in the control group (no RIS) to 43% in the RIS group. Mortality was also significantly reduced from 30.5% (control group) to 18.8% in the RIS group. Furthermore, RIS did not increase the rate of symptomatic intracranial hemorrhage. Of course, this meta-analysis is only based on observational data and needs to be confirmed in a randomized trial to bring the highest level of evidence. Refractory large vessel occlusions are commonly caused by an underlying intracranial atherosclerotic plaque. Since the SAMMPRIS trial, most of the indications for the endovascular treatment of intracranial atherosclerotic stenoses have been removed. Nevertheless, there are subsets of patients who actually benefit from intracranial stenting such as patients with refractory large vessel occlusions or patients with hemodynamically significant stenoses. As such, the PISTAR trial could be a way of validating intracranial stenting in this indication. All patients admitted for a mechanical thrombectomy will be screened before the procedure. If the patient fulfills the preoperative elligibility criteria, she/he will be informed of the possibility of being included in case of a refractory occlusion. If the patients' clinical state does not allow her/him to give informed consent, she/he can still be included using an emergency consent procedure. Consents to pursue the study will be sought as soon as possible, from the patient or her/his trusted relative. If the patient meets all remaining elligibility criteria during the mechanical thrombectomy in particular if the occlusion is considered as refractory, she/he can be included and randomized. Randomization will be performed using a minimization procedure based on the recruiting center, the administration of IV thrombolysis and the location of the occlusion (anterior versus posterior circulation). The randomzation will be centralized using an online e-crf platform. The patient can be randomized in one of the two following arms - Intervention arm : RIS + best medical treatment In this arm, a dedicated antithrombotic protocol will be initiated before the deployment of the stent. The choice of antithrombotics and the need to perform additional endovascular manœuvres such as balloon angioplasty will be left at the operator's discretion. A standard protocol for antithrombotics is proposed. - Control arm : best medical treatment with no additional thrombectomy passes In this arm, the procedure is stopped and a last control angiogram is performed to confirm the absence of reperfusion. Any additional medical treatment is allowed. Follow up visits will be performed immediately after the procedure (V0), at 24hrs (V1), 72hs (V2) and 1 month (V3). The end-research visit will be performed at 3 months (+/- 15 days) and a remote safety visit will be performed at 6 months. Fermer le détail

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
AP-HP - Hôpital Bicêtre	PREMAT Kévin	En recrutement IDF	18/04/2025 07:55:40	Contacter
AP-HP - Hôpital Henri Mondor-Albert Chenevier	PREMAT Kévin	En recrutement IDF	18/04/2025 07:55:40	Contacter
AP-HP - Hôpital La Pitié-Salpêtrière	PREMAT Kévin	En recrutement IDF	18/04/2025 07:55:40	Contacter
AP-HP - Hôpital Lariboisiere-Fernand Widal	PREMAT Kévin	En recrutement IDF	18/04/2025 07:55:40	Contacter
HOPITAL FOCH	BERTRAND LAPERGUE	En recrutement IDF	05/05/2025 07:12:14	Contacter
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
APHP • Assistance Publique des Hôpitaux de Paris, Pitié-Salpêtrière hospital - 75013 - Paris - France				Contact (sur clinicalTrials)
Bicêtre Hospital (APHP) - 94270 - Le Kremlin-Bicêtre - France				Contact (sur clinicalTrials)
Bicêtre Hospital (AP-HP) - 94270 - Le Kremlin-Bicêtre - France				Contact (sur clinicalTrials)
CHRU de Nancy - 54035 - Nancy - France				Contact (sur clinicalTrials)
CHU Amiens - 80054 - Amiens - France				Contact (sur clinicalTrials)
CHU Bordeaux (Pellegrin Hospital) - 33000 - Bordeaux - France				Contact (sur clinicalTrials)
CHU Lille (Roger Salengro Hospital) - 59037 - Lille - France				Contact (sur clinicalTrials)
CHU Montpellier - Gui de Chauliac - 34295 - Montpellier - France				Contact (sur clinicalTrials)
CHU Poitiers - 86021 - Poitiers - France				Contact (sur clinicalTrials)
Lariboisière Hospital (APHP) - 75010 - Paris - France				Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

Inclusion Criteria:

- 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

Critère de non inclusion

- 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

NCT06071091 - Comparison of Permanent Intracranial Stenting Versus no Stenting in Stroke Secondary to Refractory Acute Proximal Vascular Occlusion: a Multicenter Randomized Controlled Trial (PISTAR)

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