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

Intracranial Thrombosis Clinical Trial

— VECTOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04139486
• Other study ID #: RC19_0174
• Status: Completed
• Phase: N/A
• Start date: November 26, 2019
• Est. completion date: October 3, 2022

Study information

• Verified date: December 2022
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 526
• Est. completion date: October 3, 2022
• Est. primary completion date: February 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intracranial Thrombosis
• Thrombosis

Intervention

Procedure:
• combined EMBOTRAP II or III and Contact Aspiration
refer to title
• Contact Aspiration alone
refer to title

Locations

Country	Name	City	State
France	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

Sponsors (3)

Lead Sponsor	Collaborator
Nantes University Hospital	Central Hospital, Nancy, France, University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

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