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Intracranial ThrombosisVECTORNCT04139486

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

A study testing combined EMBOTRAP II or III and Contact Aspiration and Contact Aspiration alone in people with Intracranial Thrombosis, run by Nantes University Hospital at 23 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 ... Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intracranial Thrombosis
What is being tested?
combined EMBOTRAP II or III and Contact Aspiration and Contact Aspiration alone
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
526 participants
Where
23 sitesFrance
Study dates
26 Nov 2019to 3 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

France23 sites
  • CHU Amiens-Picardie

    Amiens

  • CH Angers

    Angers

  • CH Côte Basque

    Bayonne, 64109

  • Hôpital Pellegrin - CHU Bordeaux

    Bordeaux

  • CHRU Brest

    Brest

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre

  • Hôpital Roger Salengro - CHR Lille

    Lille

  • CHU Limoges

    Limoges

  • Hospices Civils Lyon

    Lyon

  • CHU Marseille - Hôpital la Timone

    Marseille, 13385

  • CHU Gui de Chauliac

    Montpellier

  • CHU Nancy

    Nancy

  • CHU de Nantes

    Nantes

  • Fondation Ophtalmologique Adolphe de Rothschild

    Paris, 75019

  • Hôpital Ste Anne

    Paris

  • La Pitié Salpétrière

    Paris

  • CH PAU

    Pau, 64000

  • Hôpital Maison Blanche - CHU Reims

    Reims

  • Hôpital Pontchaillou - CHU Rennes

    Rennes

  • CHU Strasbourg

    Strasbourg, 67000

  • Hôpital FOCH

    Suresnes

  • Hôpital Bretonneau - CHU Tours

    Tours

  • CH Bretagne Atlantique

    Vannes

Other trials in France

About this study

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?

Read the 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.

Being tested
combined EMBOTRAP II or III and Contact Aspiration, Contact Aspiration alone
Keywords
Contact aspiration (CA), Embotrap II, Susceptibility vessel sign (SVS), Thrombus, Embotrap III
Medical subject headings
Intracranial Thrombosis, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • combined EMBOTRAP II or III and Contact AspirationProcedure or surgery

    refer to title

  • Contact Aspiration aloneProcedure or surgery

    refer to title

Study groups in NCT04139486
Study groupRoleWhat they receive
combined EMBOTRAP II or III and Contact AspirationExperimentalNot described
Receives: Procedure: combined EMBOTRAP II or III and Contact Aspiration
Contact Aspiration aloneActive comparatorNot described
Receives: Procedure: Contact Aspiration alone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At Day 0 immediately after 3 passes

Secondary outcomes (15)
  1. Near to complete first-pass effect

    Defined as a eTICI 2c/3 after first pass device

    Measured: Day 0 immediately after first pass

  2. Complete first-pass effect

    Defined as a eTICI 3 after first pass device

    Measured: Day 0 immediately after first pass

  3. Complete reperfusion

    Defined as eTICI 3 after three passes

    Measured: Day 0 immediately after three passes

  4. Final near to complete reperfusion

    Defined as eTICI 2c/3 final

    Measured: Day 0 at the end of the intervention

  5. Final complete reperfusion

    Defined as eTICI 3

    Measured: Day 0 at the end of the intervention

  6. Time to achieve eTICI 2c or better revascularization

    Time to achieve eTICI 2c or better revascularization

    Measured: Day 0

  7. Time between groin puncture to clot contact

    Time between groin puncture to clot contact

    Measured: Day 0

  8. Rate of functional independence

    Defined as a modified Rankin scale (mRS) 0-2

    Measured: At 90days

  9. Rate of excellent functional outcome

    Defined as a mRS 0-1

    Measured: At 90days

  10. The distribution of mRs scores

    Combining scores of 9 and 10

    Measured: At 90days

  11. Change in NIHSS from baseline to 24 hours

    Change in NIHSS

    Measured: Baseline and 24hours

  12. Rate of symptomatic and asymptomatic intracerebral hemorrhage

    Assessment of symptomatic and asymptomatic intracerebral hemorrhage at MRI or CT scan 24h after thrombectomy

    Measured: At 24hrs

  13. Rate of parenchymal hematoma type 1 and 2

    Assessment of parenchymal hematoma type 1 and 2

    Measured: At 24hrs

  14. Rate of all-cause mortality at 90 days

    Assessment of all-cause mortality at 90 days

    Measured: At 90days

  15. Rate of periprocedural complications

    Occurrence of emboli to new territory, vasospasm, dissection, perforation and subarachnoid hemorrhage

    Measured: At 90days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2019
  2. Study start26 Nov 2019
  3. Primary completion14 Feb 2022
  4. Study completion3 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
526 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04139486
Sponsor's protocol ID
RC19_0174
Acronym
VECTOR
Status last verified
Dec 2022
First submitted
7 Oct 2019
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38876748

Questions about this trial

What is this clinical trial studying?

A study testing combined EMBOTRAP II or III and Contact Aspiration and Contact Aspiration alone in people with Intracranial Thrombosis, run by Nantes University Hospital at 23 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04139486, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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