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EXCELLENT Registry: A Prospective, Multicenter, Global Registry of Endovascular Stroke Treatment with the EMBOTRAP Device

  • Raul G. Nogueira
  • , Tommy Andersson
  • , Diogo C. Haussen
  • , Albert J. Yoo
  • , Ricardo A. Hanel
  • , Osama O. Zaidat
  • , Werner Hacke
  • , Tudor G. Jovin
  • , Jens Fiehler
  • , Simon F. De Meyer
  • , Waleed Brinjikji
  • , Karen M. Doyle
  • , David F. Kallmes
  • , David S. Liebeskind
  • , Renu Virmani
  • , Malgosia A. Kokoszka
  • , Violiza Inoa
  • , William Humphries
  • , Keith B. Woodward
  • , Pascal M. Jabbour
  • Olivier François, Elad I. Levy, Hormozd Bozorgchami, Stephan Boor, Jose E. Cohen, Shervin R. Dashti, Muhammad A. Taqi, Ronald F. Budzik, Clemens M. Schirmer, M. Shazam Hussain, Laurent Estrade, Reade A. De Leacy, Ajit S. Puri, Rohan V. Chitale, Caspar Brekenfeld, Adnan H. Siddiqui
  • University of Pittsburgh
  • Karolinska Institutet
  • Grady Health System
  • Texas Stroke Institute
  • Baptist Neurological Institute
  • Mercy Health, Ohio
  • Heidelberg University 
  • Cooper University Health Care
  • University of Hamburg
  • KU Leuven
  • Mayo Clinic Rochester, MN
  • University of Galway
  • University of California at Los Angeles
  • CVPath Institute, Inc.
  • Johnson & Johnson
  • University of Tennessee Health Science Center
  • Semmes-Murphey Neurologic and Spine Institute
  • Kennestone Hospital
  • Fort Sanders Regional Medical Center
  • Thomas Jefferson University
  • AZ Groeninge
  • Oregon Health and Science University
  • Johannes Gutenberg University Mainz
  • Hadassah University Medical Centre
  • Billings Clinic
  • Los Robles Medical Center
  • Riverside Methodist Hospital
  • Geisinger Medical Center
  • Cleveland Clinic Foundation
  • Centre Hospitalier Universitaire de Lille
  • Icahn School of Medicine at Mount Sinai
  • University of Massachusetts Boston
  • Vanderbilt University

Research output: Contribution to journalArticlepeer-review

11 Scopus citations

Abstract

BACKGROUND: The EXCELLENT registry aimed to evaluate the effectiveness of the EMBOTRAP Revascularization Device in an all-comer population in a real-world setting, with a focus on the composition of retrieved clots. METHODS: EXCELLENT is a prospective, global registry of patients with acute ischemic stroke treated with EMBOTRAP as the first-line mechanical thrombectomy device conducted at 34 sites (25 sites contributing clot) from September 2018 to March 2021, utilizing core imaging and central histology laboratories blinded to clinical data, independent 90-day modified Rankin Scale assessment and Clinical Events Committee. RESULTS: After screening 3799 patients, a total of 997 subjects (mean age, 70.0±14.2 years; 51.8% women; 19.7% non-White) were included. The first-pass modified Treatment in Cerebral Infarction (mTICI) ≥2b rate was 64.5% (623/966), first-pass mTICI ≥2c was 39.1% (378/966), and final mTICI ≥2b was 94.5% (931/985). A total of 427/912 (46.8%) patients achieved a 90-day modified Rankin Scale of 0 to 2 or ≤baseline. Embolization to a new territory occurred in 0.2% (2/984), and symptomatic intracranial hemorrhage at 24 hours in 1.6% (16/997). The 90-day mortality was 19.1% (175/918). Device-and/or procedure-related serious adverse events occurred in 5.9% (54/912) through 90 days. The mean RBC percentage of retrieved clots was 45.62±21.372. Among patients who achieved mTICI ≥2b with the first pass, 15.7% (52/331) and 9.7% (32/331), respectively, had RBC-poor (<25%) and RBC-rich (>75%) clots. Patients with no clot retrieved in any procedural pass had a lower percentage of hyperdense or susceptibility vessel sign on baseline imaging (58.9% versus 74.7%; P<0.001), pointing to a potential preprocedure indicator of challenging clot. CONCLUSIONS: The EXCELLENT registry informs real-world practices in mechanical thrombectomy and sheds light on the range of clots effectively retrieved by current technology. This is the first report of detailed patient characteristics where mechanical thrombectomy maneuvers failed to remove any clot material. Although the composition of nonretrievable clots cannot be assessed histologically, the results support the notion that no retrieval may be correlated with imaging findings suggesting clots lower in RBC.

Original languageEnglish
Pages (from-to)2804-2814
Number of pages11
JournalStroke
Volume55
Issue number12
DOIs
StatePublished - Dec 1 2024

Keywords

  • cerebral infarction
  • humans
  • intracranial hemorrhages
  • ischemic stroke
  • thrombectomy

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