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

NCT04139486 | Completed DMC

• 1 other identifier: RC19_0174
• Study Type: interventional
• Target: 526
• Locations: 1 country
• Sites: 23

Brief 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?

Conditions

Intracranial Thrombosis

Keywords

Contact aspiration (CA); Embotrap II; Susceptibility vessel sign (SVS); Thrombus; Embotrap III

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Near to complete first-pass effect

  Day 0 immediately after first pass

• Complete first-pass effect

  Day 0 immediately after first pass

• Complete reperfusion

  Day 0 immediately after three passes

• Final near to complete reperfusion

  Day 0 at the end of the intervention

• Final complete reperfusion

  Day 0 at the end of the intervention

Study Arms (2)

combined EMBOTRAP II or III and Contact Aspiration

EXPERIMENTAL

Procedure: combined EMBOTRAP II or III and Contact Aspiration

Contact Aspiration alone

ACTIVE COMPARATOR

Procedure: Contact Aspiration alone

Interventions

combined EMBOTRAP II or III and Contact Aspiration PROCEDURE

refer to title

combined EMBOTRAP II or III and Contact Aspiration

Contact Aspiration alone PROCEDURE

refer to title

Contact Aspiration alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• With or without intravenous thrombolysis

You may not qualify if:

• 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
• Patient with modified Rankin score \> 3 before qualifying stroke

Sponsors & Collaborators

• Nantes University Hospital: lead
• University Hospital, Lille: collaborator
• Central Hospital, Nancy, France: collaborator

Study Sites (23)

CHU Amiens-Picardie

Amiens, France

Location

CH Angers

Angers, France

Location

CH Côte Basque

Bayonne, 64109, France

Location

Hôpital Pellegrin - CHU Bordeaux

Bordeaux, France

Location

CHRU Brest

Brest, France

Location

Hôpital Bicêtre

Le Kremlin-Bicêtre, France

Location

Hôpital Roger Salengro - CHR Lille

Lille, France

Location

CHU Limoges

Limoges, France

Location

Hospices Civils Lyon

Lyon, France

Location

CHU Marseille - Hôpital la Timone

Marseille, 13385, France

Location

CHU Gui de Chauliac

Montpellier, France

Location

CHU Nancy

Nancy, France

Location

CHU de Nantes

Nantes, France

Location

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

Hôpital Ste Anne

Paris, France

Location

La Pitié Salpétrière

Paris, France

Location

CH PAU

Pau, 64000, France

Location

Hôpital Maison Blanche - CHU Reims

Reims, France

Location

Hôpital Pontchaillou - CHU Rennes

Rennes, France

Location

CHU Strasbourg

Strasbourg, 67000, France

Location

Hôpital FOCH

Suresnes, France

Location

Hôpital Bretonneau - CHU Tours

Tours, France

Location

CH Bretagne Atlantique

Vannes, France

Location

Related Publications (1)

• 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.

  PMID: 38876748 DERIVED

MeSH Terms

Conditions

Intracranial Thrombosis; Thrombosis

Condition Hierarchy (Ancestors)

Intracranial Embolism and Thrombosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Thromboembolism; Embolism and Thrombosis

Study Officials

• Romain Bourcier

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Open-label study with blinded evaluation (PROBE)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 25, 2019
• Study Start: November 26, 2019
• Primary Completion: February 14, 2022
• Study Completion: October 3, 2022
• Last Updated: December 16, 2022

Record last verified: 2022-12

Locations

FR (23)