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Common Data Elements Analysis of Mechanical Thrombectomy Clinical Trials for Acute Ischemic Stroke with Large Core Infarct

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Clinical trials addressing large core acute ischemic stroke (AIS) are ongoing across multiple international groups. Future development of clinical guidelines depends on meta-analyses of these trials calling for a degree of homogeneity of elements across the studies. This common data element study aims to provide an overview of key features of pertinent large core infarct trials.


PubMed and databases were screened for published and ongoing clinical trials assessing mechanical thrombectomy in patients with AIS with large core infarct. Nested Knowledge AutoLit living review platform was utilized to categorize primary and secondary outcomes as well as inclusion and exclusion criteria for patient selection in the trials.


The most reported data element was ASPECTS score but with varied definitions of what constitutes large core. Non-utility-weighted modified Rankin score (mRS) was reported in 6/7 studies as the primary outcome, while the utility-weighted mRS was the outcome of interest in the TESLA trial, all of them at the 3 months mark, with only LASTE looking for mRS shift at the 6 months mark. Secondary outcomes had more variations. Mortality is reported separately only in 4/7 trials, all at the 3‑month mark. Additionally, the TENSION trial reported the frequency of serious adverse events, including mortality, at the 1‑week and 12-month mark.


Overall, in large core trials there is a large degree of heterogeneity in the collected data elements. Differences in definition and timepoints render reaching a unified standard difficult, which hinders high quality meta-analyses and cohesive evidence-driven synthesis.

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  1. GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020;396:1204-22. Erratum in: Lancet. 2020;396:1562.

  2. Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019;50:e344-418. Erratum in: Stroke. 2019;50:e440–1.

    Article  PubMed  Google Scholar 

  3. Jovin TG, Chamorro A, Cobo E, de Miquel MA, Molina CA, Rovira A, San Román L, Serena J, Abilleira S, Ribó M, Millán M, Urra X, Cardona P, López-Cancio E, Tomasello A, Castaño C, Blasco J, Aja L, Dorado L, Quesada H, Rubiera M, Hernandez-Pérez M, Goyal M, Demchuk AM, von Kummer R, Gallofré M, Dávalos A; REVASCAT Trial Investigators. Thrombectomy within 8 hours after symptom onset in ischemic stroke. N Engl J Med. 2015;372:2296–306.

    Article  CAS  Google Scholar 

  4. Nogueira RG, Jadhav AP, Haussen DC, Bonafe A, Budzik RF, Bhuva P, Yavagal DR, Ribo M, Cognard C, Hanel RA, Sila CA, Hassan AE, Millan M, Levy EI, Mitchell P, Chen M, English JD, Shah QA, Silver FL, Pereira VM, Mehta BP, Baxter BW, Abraham MG, Cardona P, Veznedaroglu E, Hellinger FR, Feng L, Kirmani JF, Lopes DK, Jankowitz BT, Frankel MR, Costalat V, Vora NA, Yoo AJ, Malik AM, Furlan AJ, Rubiera M, Aghaebrahim A, Olivot JM, Tekle WG, Shields R, Graves T, Lewis RJ, Smith WS, Liebeskind DS, Saver JL, Jovin TG; DAWN Trial Investigators. Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct. N Engl J Med. 2018;378:11–21.

    Article  Google Scholar 

  5. Goyal M, Menon BK, van Zwam WH, Dippel DW, Mitchell PJ, Demchuk AM, Dávalos A, Majoie CB, van der Lugt A, de Miquel MA, Donnan GA, Roos YB, Bonafe A, Jahan R, Diener HC, van den Berg LA, Levy EI, Berkhemer OA, Pereira VM, Rempel J, Millán M, Davis SM, Roy D, Thornton J, Román LS, Ribó M, Beumer D, Stouch B, Brown S, Campbell BC, van Oostenbrugge RJ, Saver JL, Hill MD, Jovin TG; HERMES collaborators. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet. 2016;387:1723–31.

    Article  PubMed  Google Scholar 

  6. Albers GW, Marks MP, Kemp S, Christensen S, Tsai JP, Ortega-Gutierrez S, McTaggart RA, Torbey MT, Kim-Tenser M, Leslie-Mazwi T, Sarraj A, Kasner SE, Ansari SA, Yeatts SD, Hamilton S, Mlynash M, Heit JJ, Zaharchuk G, Kim S, Carrozzella J, Palesch YY, Demchuk AM, Bammer R, Lavori PW, Broderick JP, Lansberg MG; DEFUSE 3 Investigators. Thrombectomy for Stroke at 6 to 16 Hours with Selection by Perfusion Imaging. N Engl J Med. 2018;378:708–18.

    Article  Google Scholar 

  7. Powers WJ, Derdeyn CP, Biller J, Coffey CS, Hoh BL, Jauch EC, Johnston KC, Johnston SC, Khalessi AA, Kidwell CS, Meschia JF, Ovbiagele B, Yavagal DR; American Heart Association Stroke Council. 2015 American Heart Association/American Stroke Association Focused Update of the 2013 Guidelines for the Early Management of Patients With Acute Ischemic Stroke Regarding Endovascular Treatment: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015;46:3020–35.

    Article  CAS  Google Scholar 

  8. Román LS, Menon BK, Blasco J, Hernández-Pérez M, Dávalos A, Majoie CBLM, Campbell BCV, Guillemin F, Lingsma H, Anxionnat R, Epstein J, Saver JL, Marquering H, Wong JH, Lopes D, Reimann G, Desal H, Dippel DWJ, Coutts S, du Mesnil de Rochemont R, Yavagal D, Ferre JC, Roos YBWEM, Liebeskind DS, Lenthall R, Molina C, Al Ajlan FS, Reddy V, Dowlatshahi D, Sourour NA, Oppenheim C, Mitha AP, Davis SM, Weimar C, van Oostenbrugge RJ, Cobo E, Kleinig TJ, Donnan GA, van der Lugt A, Demchuk AM, Berkhemer OA, Boers AMM, Ford GA, Muir KW, Brown BS, Jovin T, van Zwam WH, Mitchell PJ, Hill MD, White P, Bracard S, Goyal M; HERMES collaborators. Imaging features and safety and efficacy of endovascular stroke treatment: a meta-analysis of individual patient-level data. Lancet Neurol. 2018;17:895–904. Erratum in: Lancet Neurol. 2018;17:e2–3.

    Article  PubMed  Google Scholar 

  9. Leslie-Mazwi TM, Altschul D, Simonsen CZ. Thrombectomy for Patients With Large Infarct Core in Practice: Where Should the Pendulum Swing? Stroke. 2021;52:3118–20.

    Article  PubMed  Google Scholar 

  10. Ren Z, Huo X, Ma G, Tong X, Kumar J, Pressman E, Chen W, Yuan G, Wang AY, Wei M, Zhang J, Nan G, Zhu Q, Liu Y, Zhang L, Song W, Zhou Z, Wang G, Li T, Luo J, Wang E, Ling W, Ju D, Song C, Liu SD, Gui L, Li T, Liu Y, Zhao J, Guo Z, Zheng H, Sun Y, Xu N, Wang YJ, Miao Z; ANGEL-ASPECT Investigators and ANGEL-ASPECT Steering Committee. Selection criteria for large core trials: rationale for the ANGEL-ASPECT study design. J Neurointerv Surg. 2022;14:107–10.

    Article  PubMed  Google Scholar 

  11. Jadhav AP, Hacke W, Dippel DWJ, Simonsen CZ, Costalat V, Fiehler J, Thomalla G, Bendszus M, Andersson T, Mattle HP, Leslie-Mazwi TM, Mokin M, Yoo AJ, Zaidat OO, Sheth SA, Jovin TG, Liebeskind D. Select wisely: the ethical challenge of defining large core with perfusion in the early time window. J Neurointerv Surg. 2021;13:497–9.

    Article  PubMed  Google Scholar 

  12. Sarraj A, Campbell B, Ribo M, Hussain MS, Chen M, Abraham MG, Lansberg MG, Mendes Pereira V, Blackburn S, Sitton CW, Budzik RF, Pérez de la Ossa N, Arenillas JF, Wu T, Blasco J, Mullen M, Schaafsma J, Tsai JP, Sangha N, Kozak O, Gibson D, Warach S, Cordato D, Manning NW, Kleinig TJ, Olivot JM, Elijovich L, Tsivgoulis G, Alexandrov A, Jabbour P, Yan B, Kasner SE, Arthur AS, Parsons M, Grotta JC, Hassan AE, Albers GW; SELECT2 Investigators and SELECT2 Steering Committee. SELECTion criteria for large core trials: dogma or data? J Neurointerv Surg. 2021;13:500–4.

    Article  PubMed  Google Scholar 

  13. Tugwell P, Boers M, Brooks P, Simon L, Strand V, Idzerda L. OMERACT: an international initiative to improve outcome measurement in rheumatology. Trials. 2007;8:38.

    Article  PubMed  PubMed Central  Google Scholar 

  14. Ioannidis JP, Horbar JD, Ovelman CM, Brosseau Y, Thorlund K, Buus-Frank ME, Mills EJ, Soll RF. Completeness of main outcomes across randomized trials in entire discipline: survey of chronic lung disease outcomes in preterm infants. BMJ. 2015;350:h72.

    Article  PubMed  Google Scholar 

  15. Harburg L, McCormack E, Kenney K, Moore C, Yang K, Vos P, Jacobs B, Madden CJ, Diaz-Arrastia R, Bogoslovsky T. Reliability of the NINDS common data elements cranial tomography (CT) rating variables for traumatic brain injury (TBI). Brain Inj. 2017;31:174–84.

    Article  PubMed  Google Scholar 

  16. Williamson PR, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E, Tugwell P. Developing core outcome sets for clinical trials: issues to consider. Trials. 2012;13:132.

    Article  PubMed  PubMed Central  Google Scholar 

  17. Koroshetz W. A core set of trial outcomes for every medical discipline? BMJ. 2015;350:h85.

    Article  PubMed  Google Scholar 

  18. Nested Knowledge. Large core/low ASPECTS Thrombectomy trials. Accessed 20 Apr 2022.

  19. Efficacy and Safety of Thrombectomy in Stroke With Extended Lesion and Extended Time Window (Tension). Identifier: NCT03094715. Accessed 20 Apr 2022.

  20. Yoshimura S, Uchida K, Sakai N, Yamagami H, Inoue M, Toyoda K, Matsumaru Y, Matsumoto Y, Kimura K, Ishikura R, Morimoto T. Randomized Clinical Trial of Endovascular Therapy for Acute Large Vessel Occlusion with Large Ischemic Core (RESCUE-Japan LIMIT): Rationale and Study Protocol. Neurol Med Chir (Tokyo). 2022;62:156–64.

    Article  Google Scholar 

  21. Large Stroke Therapy Evaluation (LASTE). Identifier: NCT03811769. Accessed 20 Apr 2022.

  22. The TESLA Trial: Thrombectomy for Emergent Salvage of Large Anterior Circulation Ischemic Stroke (TESLA). Identifier: NCT03805308. Accessed 20 Apr 2022.

  23. SELECT2: A Randomized Controlled Trial to Optimize Patient’s Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT2). Identifier: NCT03876457. Accessed 20 Apr 2022.

  24. Study of Endovascular Therapy in Acute Anterior Circulation Large Vessel Occlusive Patients With a Large Infarct Core (ANGEL-ASPECT). Identifier: NCT04551664. Accessed 20 Apr 2022.

  25. Improving Low ASPECTS Stroke Thrombectomy (I-LAST). Identifier: NCT04862507. Accessed 20 Apr 2022.

  26. Kallmes DF, Rabinstein A, Brinjikji W. Letter by Kallmes et al Regarding Article, “Mechanical Thrombectomy in Ischemic Stroke Patients With Alberta Stroke Program Early Computed Tomography Score 0–5”. Stroke. 2019;50:e219.

    Article  PubMed  Google Scholar 

  27. Dijkland SA, Voormolen DC, Venema E, Roozenbeek B, Polinder S, Haagsma JA, Nieboer D, Chalos V, Yoo AJ, Schreuders J, van der Lugt A, Majoie CBLM, Roos YBWEM, van Zwam WH, van Oostenbrugge RJ, Steyerberg EW, Dippel DWJ, Lingsma HF; MR CLEAN Investigators. Utility-Weighted Modified Rankin Scale as Primary Outcome in Stroke Trials: A Simulation Study. Stroke. 2018;49:965–71.

    Article  PubMed  PubMed Central  Google Scholar 

  28. Budhdeo S, Chari A, Harrison O, Blazeby J. Patient-centred healthcare outcome measures: towards a unified architecture. J R Soc Med. 2014;107:300–2.

    Article  PubMed  PubMed Central  Google Scholar 

  29. Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9:322–9.

    Article  PubMed  PubMed Central  Google Scholar 

  30. Accessed 20 Apr 2022.

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Correspondence to Mohamed Sobhi Jabal.

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J. Thurnham and R. Tarchand work for Nested Knowledge Inc. K.M. Kallmes works for and holds equity in Nested Knowledge Inc, works for Conway Medical LLC, and holds equity in Superior MedicalExperts Inc. N. Hardy works for and holds equity in Nested Knowledge Inc. J.J. Heit is a consultant for Medtronic and MicroVention and is a member of the scientific and medical advisory board for iSchemaView. D.F. Kallmes has ownership in Nested Knowledge Inc, Superior Medical Experts Inc, and Conway Medical LLC; research support from Microvention, Balt USA, and Medtronic. M.S. Jabal, M.K. Ibrahim, H. Kobeissi, S. Ghozy, C. Bilgin and W. Brinjikji declare that they have no competing interests.

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Jabal, M.S., Ibrahim, M.K., Thurnham, J. et al. Common Data Elements Analysis of Mechanical Thrombectomy Clinical Trials for Acute Ischemic Stroke with Large Core Infarct. Clin Neuroradiol 33, 307–317 (2023).

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