adaptatiVe Endovascular Strategy to the CloT MRI in Large Intracranial Vessel Occlusion

  • STATUS
    Recruiting
  • End date
    Apr 24, 2022
  • participants needed
    526
  • sponsor
    Nantes University Hospital
Updated on 24 June 2021
Investigator
Romain Bourcier, MD-PhD
Primary Contact
CHRU Brest (0.4 mi away) Contact
+28 other location

Summary

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?

Description

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.

Details
Condition Cerebral Thrombosis
Treatment combined EMBOTRAP II and Contact Aspiration, Contact Aspiration alone, combined EMBOTRAP II or III and Contact Aspiration
Clinical Study IdentifierNCT04139486
SponsorNantes University Hospital
Last Modified on24 June 2021

Eligibility

Yes No Not Sure

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
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