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Millipede AspiRation 用于中风研究中的血运重建 (MARRS)

2026年6月12日 更新者：Perfuze

Millipede AspiRation 在中风研究中的血运重建

该研究的目的是检查 Millipede 系统用于因大血管闭塞 (LVO) 导致的急性缺血性中风患者血运重建时的性能和安全特性，并记录相关的临床结果。

研究概览

地位

完全的

条件

干预/治疗

详细说明

缺血性中风是一种危及生命的疾病。 在美国，每年大约有 795,000 人中风。

MARRS 研究是一项介入性、开放标签、单组、多中心、前瞻性临床研究。 该研究的目的是评估 Millipede 系统在因 LVO 导致急性缺血性中风患者中的性能和安全特性，并记录临床结果。

研究类型

介入性

注册 (实际的)

235

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 85年 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  1. 年龄≥18 岁且≤85 岁的受试者。
  2. 卒中前 mRS 评分≤ 1。
  3. 基线 NIHSS 评分≥ 6。
  4. 一种与急性脑缺血一致的新局灶性致残性神经功能缺损。

  5. 对象属于以下子组之一：

    1. 受试者不适合溶栓治疗，或
    2. 受试者有资格接受溶栓治疗，并且溶栓治疗是根据现行实践指南进行的。

  6. 对于前循环卒中，应满足以下影像学标准：

    1. 磁共振成像 (MRI) 标准：目测扩散受限体积≤ 50 mL，或
    2. 计算机断层扫描 (CT) 标准：阿尔伯塔中风项目早期 CT 评分 (ASPECTS) 6-10 基线 CT 或计算机断层扫描血管造影 (CTA) - 源图像，或体积显着降低的相对脑血流量 (rCBF) <30%（体积如果进行 CT 灌注，≤ 50 mL）。
  7. 对于后循环卒中，应满足以下影像学标准：基线 CT、CTA 源图像或弥散加权成像 (DWI) MRI 的 pcASPECTS 评分为 8 至 10 分。
  8. 介入医师估计动脉穿刺可在发病/最后一次恢复正常后 8 小时内完成。
  9. 根据适用的国家/地区特定法规获得知情同意并经 IRB/REC 批准。
  10. 颅内 ICA（包括 T 或 L 型闭塞）、MCA 的 M1 或 M2 段、颅内椎动脉或可进入的基底动脉的单个大血管闭塞（mTICI 为 0-1）的血管造影确认千足虫系统。

排除标准：

  1. 过去 3 个月内已知的既往中风。
  2. 已知怀孕或哺乳的女性。
  3. 在研究者看来，任何已知的合并症（包括 COVID-19）可能会使治疗复杂化或妨碍改善或跟进。
  4. 在入组后 30 天内，受试者目前正在或之前曾参加过另一项涉及研究设备或药物的试验。
  5. 已知有严重造影剂过敏史。
  6. 先前存在的神经或精神疾病会混淆神经或功能评估。
  7. 中风发作前预期寿命少于 6 个月。
  8. 已知在治疗时使用可卡因。
  9. 已知有凝血因子缺乏症或国际标准化比值 (INR) 超过 3.0 的口服抗凝剂治疗史。
  10. 48 小时内使用肝素治疗的已知病史，部分凝血活酶时间 (PTT) 是实验室正常值的两倍以上。
  11. 已知在 48 小时内使用直接凝血酶抑制剂治疗且 PTT 超过实验室正常值的 1.5 倍。
  12. 已知葡萄糖水平 < 50 mg/dl (2.78 mmol/L) 或 > 400 mg/dl (22.20 mmol/L)。
  13. 已知血小板计数 <50,000/µL。
  14. 临床病史、既往影像学或临床判断提示颅内闭塞为慢性。
  15. 对于所有患者，SBP >220 mmHg 和/或 DBP >120 mmHg 的严重持续性高血压；对于接受溶栓治疗的患者，尽管 SBP >185 mmHg 和/或 DBP > 110 mmHg 治疗仍持续存在高血压。
  16. 血清肌酐≥3 mg/dL 或肾小球滤过率 (GFR) <30 mL/min 的肾功能衰竭。
  17. 由于中风而持续癫痫发作。
  18. 在使用 Millipede 系统之前，最初使用动脉内溶栓剂或不同的神经血栓切除术装置进行治疗。
  19. 双侧中风或多个区域中风的临床症状。
  20. 已知脑血管炎病史。
  21. 活动性全身感染的证据（例如 败血症）。 例外：普通感冒、乙型肝炎病毒 (HBV)、丙型肝炎病毒 (HCV)。
  22. 任何已知的出血或凝血缺陷。
  23. 当前颅内出血的影像学证据。
  24. 中线偏移的显着质量效应。
  25. 近端血管中的已知动脉状况需要治疗或阻止进入阻塞部位或研究设备的安全恢复（例如，严重狭窄、颈 ICA 完全阻塞、串联阻塞）。
  26. 主动脉夹层、化脓性栓子或细菌性心内膜炎的怀疑或证据。
  27. 颅外或颅内大脑动脉夹层的证据。
  28. 动脉过度迂曲可能会妨碍通过 CTA/磁共振血管造影 (MRA) 和/或常规血管造影确定的装置放置。
  29. 多处血管闭塞的证据（例如，双侧前循环、前/后循环、大脑前动脉 (ACA) 和 MCA 并发闭塞、相同或不同区域的其他并发同侧闭塞）。
  30. CT或MRI显示占位效应或颅内肿瘤（小脑膜瘤除外，直径≤2cm）。
  31. 已知有转移的癌症。
  32. 目标治疗节段处或附近的已知动脉瘤。
  33. 已知或怀疑潜在的颅内血管病变或动脉粥样硬化病变导致目标闭塞的血管造影证据

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：单臂
千足虫系统
设备：千足虫系统
机械取栓

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
ITT Cohort: Rate of Core Lab-adjudicated Reperfusion Success Within Three Passes
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
ITT Cohort: Rate of Functional Independence
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

其他结果措施

结果测量
措施说明
大体时间
ITT Cohort: Proportion of Subjects With Successful Reperfusion After the First Pass With the Millipede 088 Catheter
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Perfuze

调查人员

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

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年10月9日

初级完成 (实际的)

2025年3月8日

研究完成 (实际的)

2025年5月12日

研究注册日期

首次提交

2023年1月26日

首先提交符合 QC 标准的

2023年1月26日

首次发布 (实际的)

2023年2月6日

研究记录更新

最后更新发布 (实际的)

2026年7月10日

上次提交的符合 QC 标准的更新

2026年6月12日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • CLIN040

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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