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| Name | Class |
|---|---|
| University Hospital, Lille | OTHER |
| Central Hospital, Nancy, France | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| combined EMBOTRAP II or III and Contact Aspiration | Experimental |
| |
| Contact Aspiration alone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| combined EMBOTRAP II or III and Contact Aspiration | Procedure | refer to title |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Day 0 immediately after 3 passes |
| Measure | Description | Time Frame |
|---|---|---|
| Near to complete first-pass effect | Defined as a eTICI 2c/3 after first pass device | Day 0 immediately after first pass |
| Complete first-pass effect | Defined as a eTICI 3 after first pass device |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Romain Bourcier | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens-Picardie | Amiens | France | ||||
| CH Angers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38876748 | Derived | 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. |
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Open-label study with blinded evaluation (PROBE)
| Contact Aspiration alone | Procedure | refer to title |
|
| Day 0 immediately after first pass |
| Complete reperfusion | Defined as eTICI 3 after three passes | Day 0 immediately after three passes |
| Final near to complete reperfusion | Defined as eTICI 2c/3 final | Day 0 at the end of the intervention |
| Final complete reperfusion | Defined as eTICI 3 | Day 0 at the end of the intervention |
| Time to achieve eTICI 2c or better revascularization | Time to achieve eTICI 2c or better revascularization | Day 0 |
| Time between groin puncture to clot contact | Time between groin puncture to clot contact | Day 0 |
| Rate of functional independence | Defined as a modified Rankin scale (mRS) 0-2 | At 90days |
| Rate of excellent functional outcome | Defined as a mRS 0-1 | At 90days |
| The distribution of mRs scores | Combining scores of 9 and 10 | At 90days |
| Change in NIHSS from baseline to 24 hours | Change in NIHSS | 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 | At 24hrs |
| Rate of parenchymal hematoma type 1 and 2 | Assessment of parenchymal hematoma type 1 and 2 | At 24hrs |
| Rate of all-cause mortality at 90 days | Assessment of all-cause mortality at 90 days | At 90days |
| Rate of periprocedural complications | Occurrence of emboli to new territory, vasospasm, dissection, perforation and subarachnoid hemorrhage | At 90days |
| Angers |
| France |
| CH Côte Basque | Bayonne | 64109 | 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 | 13385 | France |
| CHU Gui de Chauliac | Montpellier | France |
| CHU Nancy | Nancy | France |
| CHU de Nantes | Nantes | France |
| Fondation Ophtalmologique Adolphe de Rothschild | Paris | 75019 | France |
| Hôpital Ste Anne | Paris | France |
| La Pitié Salpétrière | Paris | France |
| CH PAU | Pau | 64000 | France |
| Hôpital Maison Blanche - CHU Reims | Reims | France |
| Hôpital Pontchaillou - CHU Rennes | Rennes | France |
| CHU Strasbourg | Strasbourg | 67000 | France |
| Hôpital FOCH | Suresnes | France |
| Hôpital Bretonneau - CHU Tours | Tours | France |
| CH Bretagne Atlantique | Vannes | France |
| ID | Term |
|---|---|
| D020767 | Intracranial Thrombosis |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D002542 | Intracranial Embolism and Thrombosis |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
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