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

December 15, 2022 updated by: Nantes University Hospital

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?

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

526

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Amiens, France
        • CHU Amiens-Picardie
      • Angers, France
        • CH Angers
      • Bayonne, France, 64109
        • CH Cote Basque
      • Bordeaux, France
        • Hôpital Pellegrin - CHU BORDEAUX
      • Brest, France
        • CHRU Brest
      • Le Kremlin-Bicêtre, France
        • Hôpital Bicêtre
      • Lille, France
        • Hôpital Roger Salengro - CHR Lille
      • Limoges, France
        • Chu Limoges
      • Lyon, France
        • Hospices Civils Lyon
      • Marseille, France, 13385
        • CHU Marseille - Hôpital la Timone
      • Montpellier, France
        • CHU Gui de Chauliac
      • Nancy, France
        • Chu Nancy
      • Nantes, France
        • CHU de Nantes
      • Paris, France, 75019
        • Fondation Ophtalmologique Adolphe de Rothschild
      • Paris, France
        • La Pitié Salpêtrière
      • Paris, France
        • Hôpital Ste Anne
      • Pau, France, 64000
        • CH Pau
      • Reims, France
        • Hôpital Maison Blanche - CHU Reims
      • Rennes, France
        • Hopital Pontchaillou - CHU Rennes
      • Strasbourg, France, 67000
        • CHU Strasbourg
      • Suresnes, France
        • Hopital Foch
      • Tours, France
        • Hôpital Bretonneau - CHU Tours
      • Vannes, France
        • CH Bretagne Atlantique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: combined EMBOTRAP II or III and Contact Aspiration
refer to title
Active Comparator: Contact Aspiration alone
refer to title

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: At Day 0 immediately after 3 passes
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Romain Bourcier, CHU Nantes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2019

Primary Completion (Actual)

February 14, 2022

Study Completion (Actual)

October 3, 2022

Study Registration Dates

First Submitted

October 7, 2019

First Submitted That Met QC Criteria

October 23, 2019

First Posted (Actual)

October 25, 2019

Study Record Updates

Last Update Posted (Actual)

December 16, 2022

Last Update Submitted That Met QC Criteria

December 15, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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