Evidence map›Paper›PMID 34547927›Full record

Trial reportStroke2022

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

Osama O Zaidat, Johanna T Fifi, Ashish Nanda, Benjamin Atchie, Keith Woodward, Arnd Doerfler, Alejandro Tomasello, Wondwossen Tekle, Inder Paul Singh, Charles Matouk and 12 more

Registry-linked trialAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Stroke, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03464565 (COMPLETE), which is not on this map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03464565 completednot on this map

COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device

TypeobservationalSponsorPenumbra Inc.Ran2018 to 2020Enrolled650ConditionsStroke, IschemicArmsPenumbra System
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  12. Clearance rate of contrast extravasation after endovascular therapy is associated with functional outcome and mediated by cerebral edema.Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Osama O ZaidatMercy Health St. Vincent Medical Center, Toledo, OH (O.O.Z.).ORCID 0000-0003-4881-4698
Johanna T FifiIcahn School of Medicine at Mount Sinai, New York, NY (J.T.F.).ORCID 0000-0001-7786-5668
Ashish NandaSSM St. Clare Healthcare, Fenton, MO (A.N.).
Benjamin AtchieRIA Neurovascular, Englewood, CO (B.A.).ORCID 0000-0002-2481-6632
Keith WoodwardFort Sanders Regional Medical Center, Knoxville, TN (K.W.).
Arnd DoerflerUniversitätsklinikum Erlangen, Germany (A.D.).ORCID 0000-0002-3076-3231
Alejandro TomaselloHospital Universitari Vall d'Hebron, Barcelona, Spain (A.T.).ORCID 0000-0002-6736-1535
Wondwossen TekleUniversity of Texas Rio Grande Valley - Valley Baptist Health System, Harlingen (W.T.).ORCID 0000-0001-5556-5699
Inder Paul SinghMount Sinai Health System, New York, NY (I.P.S.).
Charles MatoukYale New Haven Hospital, New Haven, CT (C.M.).ORCID 0000-0003-3234-9541
Jörg ThalwitzerKlinikum Chemnitz GmbH, Chemnitz, Germany (J.T.).ORCID 0000-0003-2630-0020
Tomasz JargiełłoSamodzielny Publiczny Szpital Kliniczny nr 4, Lublin, Poland (T.J.).
Dmitry SkrypnikMoscow City Clinical Hospital named after Davydovsky, Russia (D.S.).ORCID 0000-0001-7457-8057
Oliver BeuingUniversitätsklinikum Magdeburg, Germany (O.B.).ORCID 0000-0001-8033-063X
Jérôme BergeCHU de Bordeaux- Hôpital Pellegrin, Bordeaux, France (J.B.).ORCID 0000-0002-0709-2222
Jeffrey M KatzNorth Shore University Hospital, Northwell Health, Manhasset, NY (J.M.K.).ORCID 0000-0002-8193-3683
Alessandra BiondiJ Minjoz University Hospital, Besançon, France (A.B.).ORCID 0000-0002-3185-0740
David BonovichEden Medical Center, Castro Valley, CA (D.B.).
Sunil A ShethDepartment of Neurology, UTHealth McGovern Medical School, Houston, TX (S.A.S.).ORCID 0000-0003-0602-8509
Albert J YooTexas Stroke Institute, Dallas-Fort Worth (A.J.Y.).ORCID 0000-0002-7657-142X
Ameer E HassanMercy Health St. Vincent Medical Center, Toledo, OH (O.O.Z.).ORCID 0000-0002-7148-7616
COMPLETE Registry Investigators

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

background and purposeThe 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.

methodsCOMPLETE 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.

resultsSix 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%).

conclusionsUsing 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.

Indexed as

Cerebral AngiographyIschemic StrokeMechanical ThrombolysisRegistriesAgedAged, 80 and overFemaleFollow-Up StudiesHumansMaleMiddle AgedProspective Studiescerebral infarctionischemic strokemortalityreperfusionthrombectomy

Identifiers

PMID34547927
PMCPMC8884134

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.