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?
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
526
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refer to title
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
...and 13 more locations
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
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.
Time frame: At Day 0 immediately after 3 passes
Near to complete first-pass effect
Defined as a eTICI 2c/3 after first pass device
Time frame: Day 0 immediately after first pass
Complete first-pass effect
Defined as a eTICI 3 after first pass device
Time frame: Day 0 immediately after first pass
Complete reperfusion
Defined as eTICI 3 after three passes
Time frame: Day 0 immediately after three passes
Final near to complete reperfusion
Defined as eTICI 2c/3 final
Time frame: Day 0 at the end of the intervention
Final complete reperfusion
Defined as eTICI 3
Time frame: Day 0 at the end of the intervention
Time to achieve eTICI 2c or better revascularization
Time to achieve eTICI 2c or better revascularization
Time frame: Day 0
Time between groin puncture to clot contact
Time between groin puncture to clot contact
Time frame: Day 0
Rate of functional independence
Defined as a modified Rankin scale (mRS) 0-2
Time frame: At 90days
Rate of excellent functional outcome
Defined as a mRS 0-1
Time frame: At 90days
The distribution of mRs scores
Combining scores of 9 and 10
Time frame: At 90days
Change in NIHSS from baseline to 24 hours
Change in NIHSS
Time frame: Baseline and 24hours
Rate of symptomatic and asymptomatic intracerebral hemorrhage
Assessment of symptomatic and asymptomatic intracerebral hemorrhage at MRI or CT scan 24h after thrombectomy
Time frame: At 24hrs
Rate of parenchymal hematoma type 1 and 2
Assessment of parenchymal hematoma type 1 and 2
Time frame: At 24hrs
Rate of all-cause mortality at 90 days
Assessment of all-cause mortality at 90 days
Time frame: At 90days
Rate of periprocedural complications
Occurrence of emboli to new territory, vasospasm, dissection, perforation and subarachnoid hemorrhage
Time frame: At 90days
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