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脳卒中研究における血行再建のためのヤスデ吸引 (MARRS)

2026年6月12日 更新者：Perfuze
この研究の目的は、大型血管閉塞 (LVO) による急性虚血性脳卒中患者の血行再建に使用した場合のヤスデ システムの性能と安全性を調べ、関連する臨床転帰を記録することです。

調査の概要

状態

完了

条件

介入・治療

詳細な説明

虚血性脳卒中は生命を脅かす状態です。 毎年、米国では約 795,000 人が脳卒中を起こしています。

MARRS 研究は、インターベンション、非盲検、単群、多施設、前向き臨床研究です。 この研究の目的は、LVO による急性虚血性脳卒中を呈する患者におけるヤスデ システムの性能と安全性を評価し、臨床転帰を記録することです。

研究の種類

介入

入学 (実際)

235

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

  • アメリカ
    • Connecticut
      • New Haven、Connecticut、アメリカ、06510
        • Yale University Hospital
    • Florida
      • Jacksonville、Florida、アメリカ、32207
        • Baptist Health Research Institute
      • Tampa、Florida、アメリカ、33612
        • Tampa General Hosital
    • Georgia
      • Atlanta、Georgia、アメリカ、30322
        • EMORY
    • Illinois
      • Chicago、Illinois、アメリカ、60637
        • University of Chicago
    • New York
      • Rochester、New York、アメリカ、14620
        • University of Rochester Medical Center (URMC)
      • Stony Brook、New York、アメリカ、11794
        • Stony Brook University Hospital
    • Ohio
      • Toledo、Ohio、アメリカ、43614
        • University of Toledo
      • Toledo、Ohio、アメリカ、43606
        • ProMedica Toledo Hospital
      • Toledo、Ohio、アメリカ、43608
        • Mercy Health
    • Oregon
      • Portland、Oregon、アメリカ、97239
        • Oregon Health & Science University (OHSU)
    • Pennsylvania
      • Pittsburgh、Pennsylvania、アメリカ、15213
        • University of Pittsburgh Medical Center (UPMC)
    • Tennessee
      • Memphis、Tennessee、アメリカ、38120
        • Semmes Murphey Foundation
    • Texas
      • Harlingen、Texas、アメリカ、78550
        • Valley Baptist Medical Center
      • Houston、Texas、アメリカ、77225
        • UT Houston
  • スペイン
      • Barcelona、スペイン
        • Vall d'Hebron
      • Madrid、スペイン、28046
        • Hospital Universitario La Paz
  • フランス
      • Bordeaux、フランス、33076
        • CHU Bordeaux
      • Montpellier、フランス
        • CHU Montpellier
      • Nancy、フランス
        • CHRU de Nancy
      • Nantes、フランス、44093
        • CHU de Nantes - HGRL
      • Strasbourg、フランス、67200
        • CHRU Strasbourg
      • Toulouse、フランス
        • Toulouse University Hospital -CHU Purpan

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～85年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

説明

包含基準:

  1. -18歳以上85歳以下の被験者。
  2. -脳卒中前のmRSスコアが1以下。
  3. -ベースラインのNIHSSスコアが6以上。
  4. 急性脳虚血と一致する新たな病巣性神経障害。

  5. サブジェクトは次のサブグループのいずれかに属します:

    1. -被験者は血栓溶解療法の対象外、または
    2. -被験者は血栓溶解療法の資格があり、現在の診療ガイドラインに従って血栓溶解療法が投与されました。

  6. 前循環の脳卒中の場合、次の画像基準を満たす必要があります。

    1. 磁気共鳴画像法 (MRI) 基準: 視覚的に評価された拡散制限の量が 50 mL 以下、または
    2. コンピュータ断層撮影 (CT) 基準: ベースライン CT またはコンピュータ断層撮影血管造影法 (CTA) での Alberta Stroke Program Early CT Score (ASPECTS) 6-10 - ソース画像、または有意に低下した相対脳血流 (rCBF) の体積 <30% (体積CT 灌流を行う場合は 50 mL 以下）。
  7. 後方循環の脳卒中の場合、次の画像基準を満たす必要があります: ベースライン CT、CTA ソース画像、または拡散強調画像 (DWI) MRI で pcASPECTS スコア 8 ～ 10。
  8. インターベンション専門医は、動脈穿刺は発症から 8 時間以内に完了できると推定しています。
  9. 適用される国固有の規制に従って取得され、IRB/REC によって承認されたインフォームド コンセント。
  10. 頭蓋内 ICA (T または L 閉塞を含む)、MCA の M1 または M2 セグメント、頭蓋内椎骨動脈、または脳底動脈にアクセス可能な脳底動脈の単一の大血管閉塞 (0-1 の mTICI) の血管造影による確認ヤスデシステム。

除外基準:

  1. -過去3か月以内の既知の以前の脳卒中。
  2. 妊娠中または授乳中の女性。
  3. -治験責任医師の意見では、治療を複雑にしたり、改善やフォローアップを妨げたりする可能性のある既知の併存​​疾患（COVID-19を含む）。
  4. -被験者は、現在参加している、または以前に参加した別の試験に参加しました 治験機器または登録から30日以内の薬物。
  5. -重度のコントラストアレルギーの既知の病歴。
  6. -神経学的または機能的評価を混乱させる既存の神経学的または精神医学的疾患。
  7. -脳卒中発症前の平均余命が6か月未満。
  8. -治療時の既知のコカイン使用。
  9. -凝固因子欠乏症または国際正規化比（INR）が3.0を超える経口抗凝固療法の既知の病歴。
  10. -部分トロンボプラスチン時間（PTT）が検査室正常の2倍を超える48時間以内のヘパリンによる治療の既知の履歴。
  11. -48時間以内に直接トロンビン阻害剤による治療歴があり、PTTが検査室正常の1.5倍を超えている。
  12. -既知のグルコースレベル< 50 mg/dl (2.78 mmol/L) または > 400 mg/dl (22.20 mmol/L)。
  13. 既知の血小板数が 50,000/μL 未満。
  14. 病歴、過去の画像または臨床的判断は、頭蓋内閉塞が慢性的であることを示唆しています。
  15. すべての患者で、SBP > 220 mmHg および/または DBP > 120 mmHg の重度の持続性高血圧;血栓溶解療法で治療された患者の場合、SBP > 185 mmHg および/または DBP > 110 mmHg での治療にもかかわらず高血圧が持続した。
  16. -血清クレアチニン≥3 mg / dLまたは糸球体濾過率（GFR）<30 mL /分を伴う腎不全。
  17. 脳卒中による継続的な発作。
  18. ヤスデシステムを使用する前に、動脈内血栓溶解剤または別の神経血栓除去装置で最初に治療されました。
  19. 両側脳卒中または複数の地域での脳卒中の臨床症状。
  20. -脳血管炎の既往歴。
  21. -アクティブな全身感染の証拠（例： 敗血症）。 例外: 風邪、B 型肝炎ウイルス (HBV)、C 型肝炎ウイルス (HCV)。
  22. -既知の出血性または凝固不全。
  23. 画像上の現在の頭蓋内出血の証拠。
  24. 正中線シフトによる重大な質量効果。
  25. -治療を必要とする、または閉塞部位へのアクセスを妨げる近位血管の既知の動脈状態または治験デバイスの安全な回復（たとえば、重度の狭窄、頸部ICAの完全閉塞、タンデム閉塞）。
  26. 大動脈解離、敗血症塞栓、または細菌性心内膜炎の疑いまたは証拠。
  27. 頭蓋外または頭蓋内の大脳動脈の解離の証拠。
  28. CTA/Magnetic Resonance Angiography (MRA) および/または従来の血管造影法によって決定されるように、デバイスの配置を妨げる可能性のある過度の動脈のねじれ。
  29. -複数の血管閉塞の証拠（例、両側前循環、前/後循環、前大脳動脈（ACA）およびMCAの同時閉塞、同じまたは異なる領域での他の同時同側閉塞）。
  30. 質量効果または頭蓋内腫瘍を示すCTまたはMRI（直径2cm以下の小さな髄膜腫を除く）。
  31. -転移を伴う既知のがん。
  32. -ターゲット治療セグメントまたはその近くの既知の動脈瘤。
  33. -既知または疑われる根底にある頭蓋内血管障害または標的閉塞の原因となるアテローム性動脈硬化病変の血管造影による証拠

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：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：シングルアーム
ヤスデシステム
デバイス：ヤスデシステム
機械的血栓除去術

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
ITT Cohort: Rate of Core Lab-adjudicated Reperfusion Success Within Three Passes
時間枠：Intraprocedural
Proportion of subjects with successful reperfusion, defined as achieving a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater within ≤3 passes with the Millipede System without additional therapy. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent Core Lab.
Intraprocedural
ITT Cohort: Primary Safety Outcome
時間枠：From Day 0 (procedure) through to the 90 Day visit.
All AEs will be analyzed, with specific attention to the rate of all intracranial hemorrhage (ICH), including symptomatic intracranial hemorrhage (sICH), subarachnoid hemorrhage (SAH), non-hemorrhagic AEs capable of producing neurological deterioration, and death.
From Day 0 (procedure) through to the 90 Day visit.
ITT Cohort: Supplementary Analysis of Primary Effectiveness Endpoint
時間枠：Intraprocedural
Proportion of subjects with successful reperfusion, defined as achieving a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater within 3 passes of Millipede System without additional therapy, and where use of any additional therapy after achieving mTICI ≥b with the Millipede System is defined as failure. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent core lab.
Intraprocedural
PP Cohort: Rate of Core Lab-adjudicated Reperfusion Success Within Three Passes
時間枠：Intraprocedural
Proportion of subjects with successful reperfusion, defined as achieving a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater within ≤3 passes with the Millipede System without additional therapy. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent Core Lab.
Intraprocedural
PP Cohort: Primary Safety Outcome
時間枠：From Day 0 (procedure) through to the 90 Day visit.
All AEs will be analyzed, with specific attention to the rate of all intracranial hemorrhage (ICH), including symptomatic intracranial hemorrhage (sICH), subarachnoid hemorrhage (SAH), non-hemorrhagic AEs capable of producing neurological deterioration, and death.
From Day 0 (procedure) through to the 90 Day visit.
PP Cohort: Supplementary Analysis of Primary Effectiveness Endpoint
時間枠：Intraprocedural
Proportion of subjects with successful reperfusion, defined as achieving a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater within 3 passes of Millipede System without additional therapy, and where use of any additional therapy after achieving mTICI ≥b with the Millipede System is defined as failure. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent core lab.
Intraprocedural

二次結果の測定

結果測定
メジャーの説明
時間枠
ITT Cohort: Rate of Functional Independence
時間枠：90 days post-procedure

The proportion of patients achieving modified Rankin Scale (mRS) score ≤2, evaluated by certified assessors.

The mRS scale ranges from 0 (no symptoms) to 5 (severe disability), with an additional category of 6 for death.
90 days post-procedure
ITT Cohort: Rate of All-Cause Mortality
時間枠：90 days post-procedure
Proportion of subjects that died within 90 days of the procedure
90 days post-procedure
ITT Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH)
時間枠：24-hours post-procedure
Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the Core Lab and Clinical Events Committee
24-hours post-procedure
ITT Cohort: Rate of All Intracranial Hemorrhage (ICH)
時間枠：24 hours post-procedure
Proportion of subjects with any ICH at 24 hours, as adjudicated by the Core Lab
24 hours post-procedure
ITT Cohort: Rate of Serious Adverse Device Effects (SADEs)
時間枠：90 days post-procedure
Proportion of subjects experiencing one or more SADEs within 90 days post-procedure, as adjudicated by an independent Clinical Events Committee
90 days post-procedure
ITT Cohort: Rate of Procedure-Related Serious Adverse Events (PRSAEs)
時間枠：90 days post-procedure
Proportion of subjects experiencing one or more procedure-related serious adverse events within 90 days post-procedure, as adjudicated by an independent Clinical Events Committee
90 days post-procedure
ITT Cohort: Rate of Embolization to New Territory (ENT)
時間枠：Intraprocedural
Proportion of subjects with distal emboli on final angiography, as adjudicated by an independent Core Lab
Intraprocedural
ITT Cohort: Proportion of Subjects With Successful Reperfusion at End of the Thrombectomy Procedure
時間枠：Intraprocedural
Proportion of subjects with mTICI ≥2b at the end of the procedure. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b at the end of the procedure, as adjudicated by an independent Core Lab.
Intraprocedural
ITT Cohort: Proportion of Subjects With Complete or Near Complete Reperfusion at End of the Thrombectomy Procedure
時間枠：Intraprocedural
Proportion of subjects with mTICI ≥2c at the end of the procedure. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2c at the end of the procedure, as adjudicated by an independent Core Lab.
Intraprocedural
ITT Cohort: Proportion of Subjects With Successful Reperfusion After the First Pass With the Millipede System
時間枠：Intraprocedural
Proportion of subjects with mTICI ≥2b after the first pass with the Millipede System. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b after the first pass with the Millipede System, as adjudicated by an independent Core Lab.
Intraprocedural
ITT Cohort: Proportion of Subjects With Complete or Near Complete Reperfusion at the End of the First Pass With the Millipede System
時間枠：Intraprocedural
Proportion of subjects with mTICI ≥2c after the first pass with the Millipede System. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2c after the first pass with the Millipede System, as adjudicated by an independent Core Lab.
Intraprocedural
PP Cohort: Rate of Functional Independence
時間枠：90 days post-procedure

The proportion of patients achieving modified Rankin Scale (mRS) score ≤2, evaluated by certified assessors.

The mRS scale ranges from 0 (no symptoms) to 5 (severe disability), with an additional category of 6 for death.
90 days post-procedure
PP Cohort: Rate of All-Cause Mortality
時間枠：90 days post-procedure
Proportion of subjects that died within 90 days of the procedure
90 days post-procedure
PP Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH)
時間枠：24-hours post-procedure
Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the Core Lab and Clinical Events Committee
24-hours post-procedure
PP Cohort: Rate of All Intracranial Hemorrhage (ICH)
時間枠：24 hours post-procedure
Proportion of subjects with any ICH at 24 hours, as adjudicated by the Core Lab
24 hours post-procedure
PP Cohort: Rate of Embolization to New Territory (ENT)
時間枠：Intraprocedural
Proportion of subjects with distal emboli on final angiography, as adjudicated by an independent Core Lab
Intraprocedural
PP Cohort: Proportion of Subjects With Successful Reperfusion at End of the Thrombectomy Procedure
時間枠：Intraprocedural
Proportion of subjects with mTICI ≥2b at the end of the procedure. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b at the end of the procedure, as adjudicated by an independent Core Lab.
Intraprocedural
PP Cohort: Proportion of Subjects With Complete or Near Complete Reperfusion at End of the Thrombectomy Procedure
時間枠：Intraprocedural
Proportion of subjects with mTICI ≥2c at the end of the procedure. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2c at the end of the procedure, as adjudicated by an independent Core Lab.
Intraprocedural
PP Cohort: Proportion of Subjects With Successful Reperfusion After the First Pass With the Millipede System
時間枠：Intraprocedural
Proportion of subjects with mTICI ≥2b after the first pass with the Millipede System. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b after the first pass with the Millipede System, as adjudicated by an independent Core Lab.
Intraprocedural
PP Cohort: Proportion of Subjects With Complete or Near Complete Reperfusion at the End of the First Pass With the Millipede System
時間枠：Intraprocedural
Proportion of subjects with mTICI ≥2c after the first pass with the Millipede System. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2c after the first pass with the Millipede System, as adjudicated by an independent Core Lab.
Intraprocedural

その他の成果指標

結果測定
メジャーの説明
時間枠
ITT Cohort: Proportion of Subjects With Successful Reperfusion After the First Pass With the Millipede 088 Catheter
時間枠：Intraprocedural
Proportion of subjects with mTICI ≥2b after the first pass with the Millipede 088 Catheter. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b after the first pass with the Millipede 088 Catheter, as adjudicated by an independent Core Lab.
Intraprocedural
ITT Cohort: Proportion of Subjects With Near Complete or Complete Reperfusion After the First Pass With the Millipede 088 Catheter
時間枠：Intraprocedural
Proportion of subjects with mTICI ≥2c after the first pass with the Millipede 088 Catheter. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2c after the first pass with the Millipede 088 Catheter, as adjudicated by an independent Core Lab.
Intraprocedural
ITT Cohort: Proportion of Subjects With M1 Occlusions Achieving Successful Reperfusion After the First Pass With the Millipede 088 Catheter
時間枠：Intraprocedural
Proportion of subjects with M1 occlusions achieving mTICI ≥2b after the first pass with the Millipede 088 Catheter. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants with M1 occlusions who achieved mTICI ≥2b after the first pass with the Millipede 088 Catheter, as adjudicated by an independent Core Lab.
Intraprocedural
ITT Cohort: Proportion of Subjects With M1 Occlusions Achieving Near Complete or Complete Reperfusion After the First Pass With the Millipede 088 Catheter
時間枠：Intraprocedural
Proportion of subjects with M1 occlusions achieving mTICI ≥2c after the first pass with the Millipede 088 Catheter. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants with M1 occlusions who achieved mTICI ≥2c after the first pass with the Millipede 088 Catheter, as adjudicated by an independent Core Lab.
Intraprocedural
PP Cohort: Proportion of Subjects With Successful Reperfusion After the First Pass With the Millipede 088 Catheter
時間枠：Intraprocedural
Proportion of subjects with mTICI ≥2b after the first pass with the Millipede 088 Catheter. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b after the first pass with the Millipede 088 Catheter, as adjudicated by an independent Core Lab.
Intraprocedural
PP Cohort: Proportion of Subjects With Near Complete or Complete Reperfusion After the First Pass With the Millipede 088 Catheter
時間枠：Intraprocedural
Proportion of subjects with mTICI ≥2c after the first pass with the Millipede 088 Catheter. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2c after the first pass with the Millipede 088 Catheter, as adjudicated by an independent Core Lab.
Intraprocedural
PP Cohort: Proportion of Subjects With M1 Occlusions Achieving Successful Reperfusion After the First Pass With the Millipede 088 Catheter
時間枠：Intraprocedural
Proportion of subjects with M1 occlusions achieving mTICI ≥2b after the first pass with the Millipede 088 Catheter. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants with M1 occlusions who achieved mTICI ≥2b after the first pass with the Millipede 088 Catheter, as adjudicated by an independent Core Lab.
Intraprocedural
PP Cohort: Proportion of Subjects With M1 Occlusions Achieving Near Complete or Complete Reperfusion After the First Pass With the Millipede 088 Catheter
時間枠：Intraprocedural
Proportion of subjects with M1 occlusions achieving mTICI ≥2c after the first pass with the Millipede 088 Catheter. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants with M1 occlusions who achieved mTICI ≥2c after the first pass with the Millipede 088 Catheter, as adjudicated by an independent Core Lab.
Intraprocedural

協力者と研究者

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捜査官

  • 主任研究者：Raul Nogueira, MD、University of Pittsburgh Medical Center (UPMC), Pittsburgh, USA
  • 主任研究者：Marc Ribo, MD、Vall d'Hebron Hospital, Barcelona, Spain
  • 主任研究者：Ricardo Hanel, MD、Baptist Health Research Institute, Jacksonville, USA

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)

2023年10月9日

一次修了 (実際)

2025年3月8日

研究の完了 (実際)

2025年5月12日

試験登録日

最初に提出

2023年1月26日

QC基準を満たした最初の提出物

2023年1月26日

最初の投稿 (実際)

2023年2月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月10日

QC基準を満たした最後の更新が送信されました

2026年6月12日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • CLIN040

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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

はい

米国で製造され、米国から輸出された製品。

いいえ

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