Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2022 Mar;53(3):769-778.
doi: 10.1161/STROKEAHA.121.034268. Epub 2021 Sep 22.

Endovascular Treatment of Acute Ischemic Stroke With the Penumbra System in Routine Practice: COMPLETE Registry Results

Osama O Zaidat  1 , Johanna T Fifi  2 , Ashish Nanda  3 , Benjamin Atchie  4 , Keith Woodward  5 , Arnd Doerfler  6 , Alejandro Tomasello  7 , Wondwossen Tekle  8 , Inder Paul Singh  9 , Charles Matouk  10 , Jörg Thalwitzer  11 , Tomasz Jargiełło  12 , Dmitry Skrypnik  13 , Oliver Beuing  14 , Jérôme Berge  15 , Jeffrey M Katz  16 , Alessandra Biondi  17 , David Bonovich  18 , Sunil A Sheth  19 , Albert J Yoo  20 , Ameer E Hassan  1   21 ; COMPLETE Registry Investigators
Affiliations
Clinical Trial

Endovascular Treatment of Acute Ischemic Stroke With the Penumbra System in Routine Practice: COMPLETE Registry Results

Osama O Zaidat et al. Stroke. 2022 Mar.

Abstract

Background and purpose: The purpose of the COMPLETE (International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device) registry was to evaluate the generalizability of the safety and efficacy of the Penumbra System (Penumbra, Inc, Alameda) in a real-world setting.

Methods: COMPLETE was a global, prospective, postmarket, multicenter registry. Patients with large vessel occlusion-acute ischemic stroke who underwent mechanical thrombectomy using the Penumbra System with or without the 3D Revascularization Device as frontline approach were enrolled at 42 centers (29 United States, 13 Europe) from July 2018 to October 2019. Primary efficacy end points were successful postprocedure angiographic revascularization (modified Thrombolysis in Cerebral Infarction ≥2b) and 90-day functional outcome (modified Rankin Scale score 0-2). The primary safety end point was 90-day all-cause mortality. An imaging core lab determined modified Thrombolysis in Cerebral Infarction scores, Alberta Stroke Program Early CT Scores, clot location, and occurrence of intracranial hemorrhage at 24 hours. Independent medical reviewers adjudicated safety end points.

Results: Six hundred fifty patients were enrolled (median age 70 years, 54.0% female, 49.2% given intravenous recombinant tissue-type plasminogen activator before thrombectomy). Rate of modified Thrombolysis in Cerebral Infarction 2b to 3 postprocedure was 87.8% (95% CI, 85.3%-90.4%). First pass and postprocedure rates of modified Thrombolysis in Cerebral Infarction 2c to 3 were 41.5% and 66.2%, respectively. At 90 days, 55.8% (95% CI, 51.9%-59.7%) had modified Rankin Scale score 0 to 2, and all-cause mortality was 15.5% (95% CI, 12.8%-18.3%).

Conclusions: Using Penumbra System for frontline mechanical thrombectomy treatment of patients with large vessel occlusion-acute ischemic stroke in a real-world setting was associated with angiographic, clinical, and safety outcomes that were comparable to prior randomized clinical trials with stringent site and operator selection criteria. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03464565.

Keywords: cerebral infarction; ischemic stroke; mortality; reperfusion; thrombectomy.

PubMed Disclaimer

Figures

Figure.
Figure.
Distribution of the modified Rankin Scale (mRS) scores at 90 d for the full study population (all patients) and the pre-specified cohorts (Cohort A, ASPECTS [Alberta Stroke Program Early CT Score] 6-10; cohort B, ASPECTS 0-5, large core infarct; and cohort C, posterior circulation occlusion).
See this image and copyright information in PMC

References

    1. Turc G, Bhogal P, Fischer U, Khatri P, Lobotesis K, Mazighi M, Schellinger PD, Toni D, de Vries J, White P, et al. . European Stroke Organisation (ESO) - European Society for Minimally Invasive Neurological Therapy (ESMINT) Guidelines on Mechanical Thrombectomy in Acute Ischaemic StrokeEndorsed by Stroke Alliance for Europe (SAFE). Eur Stroke J. 2019;4:6–12. doi: 10.1177/2396987319832140 - PMC - PubMed
    1. Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, et al. . 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–e418. doi: 10.1161/STR.0000000000000211 - PubMed
    1. Berkhemer OA, Fransen PS, Beumer D, van den Berg LA, Lingsma HF, Yoo AJ, Schonewille WJ, Vos JA, Nederkoorn PJ, Wermer MJ, et al. ; MR CLEAN Investigators. A randomized trial of intraarterial treatment for acute ischemic stroke. N Engl J Med. 2015;372:11–20. doi: 10.1056/NEJMoa1411587 - PubMed
    1. Bracard S, Ducrocq X, Mas JL, Soudant M, Oppenheim C, Moulin T, Guillemin F; THRACE investigators. Mechanical thrombectomy after intravenous alteplase versus alteplase alone after stroke (THRACE): a randomised controlled trial. Lancet Neurol. 2016;15:1138–1147. doi: 10.1016/S1474-4422(16)30177-6 - PubMed
    1. Campbell BC, Mitchell PJ, Kleinig TJ, Dewey HM, Churilov L, Yassi N, Yan B, Dowling RJ, Parsons MW, Oxley TJ, et al. ; EXTEND-IA Investigators. Endovascular therapy for ischemic stroke with perfusion-imaging selection. N Engl J Med. 2015;372:1009–1018. doi: 10.1056/NEJMoa1414792 - PubMed

Publication types

Associated data