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

2026年9月10日 更新者：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?

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

526

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：combined EMBOTRAP II or III and Contact Aspiration
手順：combined EMBOTRAP II or III and Contact Aspiration
refer to title
アクティブコンパレータ：Contact Aspiration alone
手順：Contact Aspiration alone
refer to title

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
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
時間枠：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

二次結果の測定

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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Nantes University Hospital

協力者

Central Hospital, Nancy, France
University Hospital, Lille

捜査官

  • 主任研究者：Romain Bourcier、Nantes university hospital

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2019年11月26日

一次修了 (実際)

2022年2月14日

研究の完了 (実際)

2022年10月3日

試験登録日

最初に提出

2019年10月7日

QC基準を満たした最初の提出物

2019年10月23日

最初の投稿 (実際)

2019年10月25日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月14日

QC基準を満たした最後の更新が送信されました

2026年9月10日

最終確認日

2022年12月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • RC19_0174

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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