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SNIS 21st annual meeting late-breaking oral abstracts
LB-007 The imperative trial: an FDA approved prospective multi-center trial including super-large bore aspiration thrombectomy
  1. W Mack1,
  2. R Nogueira2,
  3. J Grossberg3,
  4. S Majidi4,
  5. D Tomalty5,
  6. M Mokin6,
  7. J Vargas7,
  8. B Cucchiara8,
  9. K Snyder9,
  10. J Mascitelli10,
  11. V Parada11,
  12. H Shakir12,
  13. D Rosenbaum-HaLevi13,
  14. N Aghaebrahim14,
  15. D Hoit15,
  16. B Yim16,
  17. M Tenser1,
  18. A Al-Bayati2,
  19. J Milburn17,
  20. J Singer18,
  21. S Nimjee19,
  22. N Haranhalli20,
  23. S Sheth21,
  24. D Shaff22,
  25. K Layton23,
  26. N Beaty24,
  27. R Starke25,
  28. H Hawk26,
  29. D Haussen3,
  30. A Pabaney3,
  31. C Kellner4,
  32. R De Leacy4
  1. 1University of Southern California, Los Angeles, CA
  2. 2University of Pittsburgh Medical Center, Pittsburg, PA
  3. 3Emory University School of Medicine, Atlanta, GA
  4. 4Icahn School of Medicine at Mount Sinai, New York, NY
  5. 5Huntsville Hospital, Huntsville, AL
  6. 6University of South Florida, Tampa, FL
  7. 7Prisma Health, Greenville, SC
  8. 8University of Pennsylvania, Philadelphia, PA
  9. 9Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY
  10. 10University of Texas Health Science Center at San Antonio, San Antonio, TX
  11. 11Valley Baptist Medical Center/University of Texas Rio Grande Valley, Harlingen, TX
  12. 12The Oklahoma University Health Sciences Center, Oklahoma City, OK
  13. 13Munson Medical Center, Traverse City, MI
  14. 14Baptist Neurological Institute, Lyerly Neurosurgery, Jacksonville, FL
  15. 15Semmes-Murphey Neurologic and Spine Institute, University of Tennessee Health Sciences Center, Memphis, TN
  16. 16John Muir Health Medical Center, Walnut Creek, CA
  17. 17Ochsner Medical System, New Orleans, CA
  18. 18Spectrum Health, Grand Rapids, MI
  19. 19Ohio State University, Columbus, OH
  20. 20Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY
  21. 21Memorial Hermann, UTHealth McGovern Medical School, Houston, TX
  22. 22Lehigh Valley Hospital, Allentown, PA
  23. 23Baylor University Medical Center, Dallas, TX
  24. 24Tallahassee Memorial Hospital Florida State University, Tallahassee, FL
  25. 25University of Miami Health System, Miami, FL
  26. 26Erlanger Health System, Chattanooga, TN

Abstract

Introduction/Purpose This FDA approved trial, with independent adjudication of primary endpoints, was conducted to evaluate a novel aspiration thrombectomy system, including 0.088’ super-large bore aspiration catheters (Zoom Reperfusion System; Imperative Care, Inc., Cambell, California). Pre-specified performance goals were established in conjunction with the FDA.

Materials and Methods Prospectively consented patients meeting inclusion and exclusion criteria were treated across 26 United States institutions from October 2021 to March 2024. Data analysis will be conducted according to the FDA approved pre-specified statistical analysis plan. All data are near-final but should be considered preliminary until final confirmation before SNIS. Endpoints reported herein include: core-lab adjudicated symptomatic intracranial hemorrhage (sICH) rate per ECASS III definition; 90-day all-cause mortality; and site-reported rate of modified Thrombolysis in Cerebral Infarction (mTICI) ≥2B achieved using the primary treatment modality (only Zoom system) without any additional therapies within ≤3 passes (ongoing core lab adjudication of angiograms will be complete by end of June 2024 and presented at SNIS). Secondary outcomes include rate of functional independence (mRS 0-2), median time to mTICI ≥2B, final mTICI ≥2B rate, use of stent retrieval thrombectomy as rescue to achieve mTICI ≥2B, and rate of rescue therapy to achieve mTICI ≥2B in ICA/M-1 occlusions according to super-large bore catheter positioning.

Results Baseline and stroke characteristics for 260 evaluable subjects are presented in table 1. Core lab adjudicated rate of sICH was 3.1% (8/260). 90-day all-cause mortality was 13% (34/255); imputing worst case scenario for five patients lost to follow-up was 15% (39/260). mTICI ≥2B within ≤3 passes without use of alternative devices was achieved in 89% (231/260), 95% CI (84%-92%); and after all passes with the Zoom system was 91% (237/260), 95% CI (87%-94%). Functional independence (mRS 0-2) was achieved in 54% (133/245) of patients. The median time from groin puncture to mTICI ≥2B was 19 (IQR 13-30) minutes. Final mTICI ≥2B rate was 97% (253/260), 95% CI (95%-99%). Stent retrieval rescue therapy required to achieve mTICI ≥2B was 5.0% (13/260). Furthermore, stent retrieval rescue therapy for ICA/M-1 occlusions was lower when super-large bore catheter positioning was higher in the carotid circulation [Cavernous or higher: 4.5% (7/154); intradural or higher: 3.4% (4/119)].

View this table:
Abstract LB-007 Table 1

Demographic and stroke characteristics of study patients (n=260)

Conclusion Initial results appear promising and will be further validated through completion of core lab adjudication. While not directly comparable, these preliminary data suggest a numerically lower rate of rescue therapy than prior thrombectomy trials. Preliminary signal suggests super-large bore catheter positioning may influence the need for stent retrieval rescue therapy.

Disclosures W. Mack: 1; C; National Institutes of Health. 2; C; Imperative Care, Medtronic, Stryker, Viseon, Integra, Stream Biomedical, Egret Therapeutics, Spartan Micro. 4; C; Viseon, Q’Apel, Cerebrotech, Endostream, Stream Biomedical, Spartan Micro, Radical Catheters, Vastrax, Borvo, Egret Therapeutics. 5; C; University of Southern California. R. Nogueira: 2; C; Imperative Care. J. Grossberg: None. S. Majidi: 2; C; Imperative Care. D. Tomalty: None. M. Mokin: 2; C; Imperative Care. J. Vargas: 2; C; Imperative Care. B. Cucchiara: None. K. Snyder: None. J. Mascitelli: None. V. Parada: None. H. Shakir: 2; C; ImperativeCare. D. Rosenbaum-HaLevi: None. N. Aghaebrahim: None. D. Hoit: 2; C; Imperative Care. B. Yim: 2; C; Imperative Care. M. Tenser: None. A. Al-Bayati: None. J. Milburn: 2; C; Imperative Care. J. Singer: None. S. Nimjee: None. N. Haranhalli: None. S. Sheth: None. D. Shaff: None. K. Layton: None. N. Beaty: None. R. Starke: None. H. Hawk: 2; C; Imperative Care. D. Haussen: None. A. Pabaney: None. C. Kellner: None. R. De Leacy: 2; C; Imperative Care.

https://doi.org/10.1136/jnis-2024-SNIS.406

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