adaptatiVe Endovascular Strategy to the CloT MRI in Large Intracranial Vessel Occlusion
NCT ID: NCT04139486
Last Updated: 2022-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
526 participants
INTERVENTIONAL
2019-11-26
2022-10-03
Brief Summary
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Many practitioners are convinced that a first line strategy with CA alone is easy, safe, rapid and efficient. Maybe, after two, three, four ... passes and with the secondary help of a combined strategy, a high rate of eTICI 2b/3 could be reached with a CA first line strategy. But this could go with a higher number of passes, a waste of time and a suboptimal angiographic results (eTICI 2b) due to distal emboli, especially in case of friable, non-well organized, red blood cell rich (RBC) i.e. SVS + thrombi (25-28). This could, be related to worst clinical outcome at 3 months. VECTOR asks a relevant question: Do the invetigators have to add the use of an Embotrap II or III to the CA, from the first passes, in case of SVS+ clots?
Detailed Description
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The susceptibility vessel sign (SVS) on T2\*-MRI sequence is defined as a hypo-intense signal exceeding the diameter of the contralateral artery located at the site of the thrombus. Several studies have demonstrated SVS to be a negative predictor of early reperfusion after IV t-PA and an incentive to EVT . Two studies identified a correlation between the SVS and the thrombus composition (specifically the RBC composition). In the ASTER trial, the presence of SVS impacted the success rate of the EVT strategy. In the SVS (+) sub-population of this study, compared to contact aspiration (CA), patients treated with stent retrievers achieved higher rates of complete reperfusion within fewer passes, which translated into a better functional outcome. In the absence of SVS, no differences were observed between the two techniques. Furthermore; based on the ASTER and THRACE trial populations treated with stent retriever as a first line strategy, a higher rate of favorable clinical outcome at 3 months in SVS (+) patients was recently found . Hence, that differences in terms of reperfusion results are thought to be related to different clot compositions between SVS + and SVS - occlusions.
In the VECTOR trial, the aim is to analyze, in case of SVS+ occlusions, a first line Embotrap II added to CA combined strategy compare to CA alone strategy.
Many practitioners are convinced that a first line strategy with CA alone is easy, safe, rapid and efficient. Maybe, after two, three, four passes and with the secondary help of a combined strategy, a high rate of eTICI 2b/3 could be reached with a CA first line strategy. But this could go with a higher number of passes, a waste of time and a suboptimal angiographic results (eTICI 2b) due to distal emboli, especially in case of friable, non-well organized, red blood cell rich (RBC) i.e. SVS + thrombi. This could, be related to worst clinical outcome at 3 months.
VECTOR asks a relevant question: Do the investigators have to add the use of an Embotrap II or III to the CA, from the first passes, in case of SVS+ clots? The hypothesis in the VECTOR trial is that the Embotrap II or III, thanks to its dedicated design will help to the stabilization of friable clots and allow better retrieving of SVS + thrombi in a lower number of passes.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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combined EMBOTRAP II or III and Contact Aspiration
combined EMBOTRAP II or III and Contact Aspiration
refer to title
Contact Aspiration alone
Contact Aspiration alone
refer to title
Interventions
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combined EMBOTRAP II or III and Contact Aspiration
refer to title
Contact Aspiration alone
refer to title
Eligibility Criteria
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Inclusion Criteria
* Puncture carried out within 24 hours of first symptoms
* Suitable 1.5T MRI T2 \* Gradient echo that shows a clear susceptibility vessel sign facing the occlusion
* Neuroimaging demonstrates large vessel proximal occlusion (distal ICA through MCA bifurcation, M1 or proximal M2)
* Patient or trustworthy person informed about the study and having orally consented to participation in the study. If the patient is unable to receive information and no trustworthy person can be contacted during screening for the study, trial inclusion will be completed as an emergency procedure by the investigator, in compliance with the French laws
* With or without intravenous thrombolysis
Exclusion Criteria
* Known or suspected pre-existing (chronic) large vessel occlusion in the symptomatic territory
* Suspected pregnancy; if, in a woman is of child-bearing potential, a urine or serum beta HCG test is positive
* Severe contrast medium allergy or absolute contraindication to use of iodinated products
* Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic
* Patient has severe or fatal comorbidities that will likely prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient
* Acute ischemic stroke involving posterior circulation (vertebro-basilar occlusion)
* Angiographic evidence of carotid dissection or tandem cervical occlusion or stenosis requiring treatment
* Pregnant or breast-feeding women
* Patient benefiting from a legal protection
* Non-membership of a national insurance scheme
* Opposition of the patient or (in case of inclusion as a matter of urgency) of the trustworthy person
* Patient with modified Rankin score \> 3 before qualifying stroke
18 Years
ALL
No
Sponsors
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University Hospital, Lille
OTHER
Central Hospital, Nancy, France
OTHER
Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Romain Bourcier
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
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CHU Amiens-Picardie
Amiens, , France
CH Angers
Angers, , France
CH Côte Basque
Bayonne, , France
Hôpital Pellegrin - CHU Bordeaux
Bordeaux, , France
CHRU Brest
Brest, , France
Hôpital Bicêtre
Le Kremlin-Bicêtre, , France
Hôpital Roger Salengro - CHR Lille
Lille, , France
CHU Limoges
Limoges, , France
Hospices Civils Lyon
Lyon, , France
CHU Marseille - Hôpital la Timone
Marseille, , France
CHU Gui de Chauliac
Montpellier, , France
CHU Nancy
Nancy, , France
CHU de Nantes
Nantes, , France
Fondation Ophtalmologique Adolphe de Rothschild
Paris, , France
Hôpital Ste Anne
Paris, , France
La Pitié Salpétrière
Paris, , France
CH PAU
Pau, , France
Hôpital Maison Blanche - CHU Reims
Reims, , France
Hôpital Pontchaillou - CHU Rennes
Rennes, , France
CHU Strasbourg
Strasbourg, , France
Hôpital FOCH
Suresnes, , France
Hôpital Bretonneau - CHU Tours
Tours, , France
CH Bretagne Atlantique
Vannes, , France
Countries
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References
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Bourcier R, Marnat G, Dargazanli C, Zhu F, Consoli A, Shotar E, Premat K, Eugene F, Janot K, L'Allinec V, Ognard J, Desilles JP, Blanc R, Gentric JC, Bourdain F, Labreuche J, Liao L, Clarencon F, Barreau X, Ifergan H, Hak JF, Kerleroux B, Pop R, Soize S, Bricout N, Caroff J, Richter JS, Desal H, Lapergue B, Rouchaud A; JENI Research Collaborative. Safety and efficacy of stent retrievers plus contact aspiration in patients with acute ischaemic anterior circulation stroke and positive susceptibility vessel sign in France (VECTOR): a randomised, single-blind trial. Lancet Neurol. 2024 Jul;23(7):700-711. doi: 10.1016/S1474-4422(24)00165-0.
Other Identifiers
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RC19_0174
Identifier Type: -
Identifier Source: org_study_id