adaptatiVe Endovascular Strategy to the CloT MRI in Large Intracranial Vessel Occlusion (VECTOR)
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 (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?
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Sudden occlusion of an intracranial artery by a thrombus represents the initial and pivotal event of large vessel occlusion acute ischemic stroke (AIS). The primary goal of AIS treatment is to re-open this artery with intravenous tissue-type plasminogen activator infusion (IV t-PA) and/or endovascular therapy (EVT). Thrombus characterization could be useful to predict AIS etiology, IV t-PA response and to adapt the device or technique for EVT. Especially, approaching the red blood cell (RBC) content of the thrombus would be helpful to plan a treatment strategy or identify specific EVT approaches in order to maximize the rate of early successful reperfusion .
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Amiens, Frankrijk
- CHU Amiens-Picardie
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Angers, Frankrijk
- CH Angers
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Bayonne, Frankrijk, 64109
- CH Côte Basque
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Bordeaux, Frankrijk
- Hôpital Pellegrin - CHU Bordeaux
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Brest, Frankrijk
- CHRU Brest
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Le Kremlin-Bicêtre, Frankrijk
- Hôpital Bicêtre
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Lille, Frankrijk
- Hôpital Roger Salengro - CHR Lille
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Limoges, Frankrijk
- CHU Limoges
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Lyon, Frankrijk
- Hospices Civils Lyon
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Marseille, Frankrijk, 13385
- CHU Marseille - Hôpital la Timone
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Montpellier, Frankrijk
- CHU Gui de Chauliac
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Nancy, Frankrijk
- CHU Nancy
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Nantes, Frankrijk
- CHU de Nantes
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Paris, Frankrijk, 75019
- Fondation Ophtalmologique Adolphe de Rothschild
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Paris, Frankrijk
- La Pitié Salpétrière
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Paris, Frankrijk
- Hôpital Ste Anne
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Pau, Frankrijk, 64000
- CH Pau
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Reims, Frankrijk
- Hôpital Maison Blanche - CHU Reims
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Rennes, Frankrijk
- Hôpital Pontchaillou - CHU Rennes
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Strasbourg, Frankrijk, 67000
- CHU Strasbourg
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Suresnes, Frankrijk
- Hôpital Foch
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Tours, Frankrijk
- Hôpital Bretonneau - CHU Tours
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Vannes, Frankrijk
- CH Bretagne Atlantique
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Age 18 and older (i.e., candidates must have had their 18th birthday)
- 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:
- Absence of large vessel occlusion on non-invasive imaging
- 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: combined EMBOTRAP II or III and Contact Aspiration
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refer to title
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Actieve vergelijker: Contact Aspiration alone
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refer to title
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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The rate of near to complete reperfusion after 3 passes of the device defined by a modified treatment in cerebral infarction (eTICI) score of 2c/3
Tijdsspanne: At Day 0 immediately after 3 passes
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Preliminary data suggested in case of SVS+ occlusions a superiority of the first line SR strategy in terms of eTICI2c/3 after 3 passes compared to first line CA alone.The first pass (FPE) is an ambitious technical endpoint defined as a successful reperfusion obtained after the first pass that has been recently associated with an increased probability of favorable clinical outcome, a reduced mortality rate and procedural adverse events.However, this constitutes a "very technical" endpoint and the external validity in daily practice would be reduced compared to the three passes cut-off.Even if a FPE eTICI 2b, 2c or 3 has shown better clinical outcome compared to a final eTICI 2b, 2c or 3,there is no study that has proved the better clinical outcome when compared FPE eTICI 2b,2c or 3 to three passes eTICI 2b,2c or 3.Last, there was no preliminary data that suggests in case of SVS+ occlusions, a superiority of the first pass SR strategy in terms eTICI2c/3 compared to first pass CA alone.
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At Day 0 immediately after 3 passes
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Near to complete first-pass effect
Tijdsspanne: Day 0 immediately after first pass
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Defined as a eTICI 2c/3 after first pass device
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Day 0 immediately after first pass
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Complete first-pass effect
Tijdsspanne: Day 0 immediately after first pass
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Defined as a eTICI 3 after first pass device
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Day 0 immediately after first pass
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Complete reperfusion
Tijdsspanne: Day 0 immediately after three passes
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Defined as eTICI 3 after three passes
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Day 0 immediately after three passes
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Final near to complete reperfusion
Tijdsspanne: Day 0 at the end of the intervention
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Defined as eTICI 2c/3 final
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Day 0 at the end of the intervention
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Final complete reperfusion
Tijdsspanne: Day 0 at the end of the intervention
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Defined as eTICI 3
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Day 0 at the end of the intervention
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Time to achieve eTICI 2c or better revascularization
Tijdsspanne: Day 0
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Time to achieve eTICI 2c or better revascularization
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Day 0
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Time between groin puncture to clot contact
Tijdsspanne: Day 0
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Time between groin puncture to clot contact
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Day 0
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Rate of functional independence
Tijdsspanne: At 90days
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Defined as a modified Rankin scale (mRS) 0-2
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At 90days
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Rate of excellent functional outcome
Tijdsspanne: At 90days
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Defined as a mRS 0-1
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At 90days
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The distribution of mRs scores
Tijdsspanne: At 90days
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Combining scores of 9 and 10
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At 90days
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Change in NIHSS from baseline to 24 hours
Tijdsspanne: Baseline and 24hours
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Change in NIHSS
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Baseline and 24hours
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Rate of symptomatic and asymptomatic intracerebral hemorrhage
Tijdsspanne: At 24hrs
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Assessment of symptomatic and asymptomatic intracerebral hemorrhage at MRI or CT scan 24h after thrombectomy
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At 24hrs
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Rate of parenchymal hematoma type 1 and 2
Tijdsspanne: At 24hrs
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Assessment of parenchymal hematoma type 1 and 2
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At 24hrs
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Rate of all-cause mortality at 90 days
Tijdsspanne: At 90days
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Assessment of all-cause mortality at 90 days
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At 90days
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Rate of periprocedural complications
Tijdsspanne: At 90days
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Occurrence of emboli to new territory, vasospasm, dissection, perforation and subarachnoid hemorrhage
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At 90days
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Romain Bourcier, Nantes university hospital
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- RC19_0174
Informatie over medicijnen en apparaten, studiedocumenten
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