COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device
NCT ID: NCT03464565
Last Updated: 2020-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
650 participants
OBSERVATIONAL
2018-07-02
2020-01-17
Brief Summary
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Detailed Description
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Registry Design: This will be a prospective, single-arm, multi-center observational registry and will include patients that present with either anterior or posterior LVO who are eligible for mechanical thrombectomy using the Penumbra System.
Registry Duration: Subjects will be in the registry for approximately 90 days from enrollment to last follow-up.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with acute ischemic stroke secondary to LVO
Penumbra System
Penumbra System
Interventions
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Penumbra System
Penumbra System
Eligibility Criteria
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Inclusion Criteria
* Pre-stroke mRS 0-1
* Patient experiencing acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy using the Penumbra System
* Planned frontline treatment with Penumbra System
* Signed informed consent per Institution Review Board/Ethics Committee
Exclusion Criteria
* Currently participating in an investigational (drug, device, etc) clinical trial that will confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.
18 Years
ALL
No
Sponsors
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Penumbra Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Osama O Zaidat, MD
Role: PRINCIPAL_INVESTIGATOR
Mercy St. Vincent Medical Center
Johanna Fifi, MD
Role: PRINCIPAL_INVESTIGATOR
Mount Sinai Health System
Ameer E. Hassan, MD
Role: PRINCIPAL_INVESTIGATOR
McAllen Medical Center
Locations
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Banner Desert Medical Center
Mesa, Arizona, United States
Eden Medical Center
Castro Valley, California, United States
St. Jude Medical Center
Fullerton, California, United States
Cedar Sinai Medical Center
Los Angeles, California, United States
Mercy San Juan Medical Center
Sacramento, California, United States
Los Robles Hospital
Thousand Oaks, California, United States
RIA
Englewood, Colorado, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Jackson Memorial Hospital
Miami, Florida, United States
Naples Community Hospital
Naples, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Oschner Medical Center
New Orleans, Louisiana, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
SSM St. Clare Healthcare
St Louis, Missouri, United States
The Valley Hospital
Ridgewood, New Jersey, United States
Northwell Health
Manhasset, New York, United States
Mount Sinai New York
New York, New York, United States
NYU Langone Hospital-Brooklyn
New York, New York, United States
Mercy St. Vincent Medical Center
Toledo, Ohio, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Palmetto Health Richland Hospital
Columbia, South Carolina, United States
Erlanger Health System
Chattanooga, Tennessee, United States
Fort Sanders Regional Medical Center
Knoxville, Tennessee, United States
Methodist University Hospital
Memphis, Tennessee, United States
Valley Baptist Medical Center
Harlingen, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
McAllen Medical Center
McAllen, Texas, United States
Swedish Medical Center-Cherry Hill
Seattle, Washington, United States
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, , France
Foundation Ophthalmic Adolphe De Rothschild
Paris, , France
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
Universitätsklinikum Erlangen
Erlangen, , Germany
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Lübeck, , Germany
Universitätsklinikum Magdeburg A. ö. R.
Magdeburg, , Germany
Samodzielny Publiczny Szpital Kliniczny
Lublin, , Poland
Davidovsky Moscow City Hospital №23
Moscow, , Russia
City Clinical Hospital No. 1
Moscow, , Russia
Multidisciplinary City Hospital №2
Saint Petersburg, , Russia
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, , Spain
Countries
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References
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Hassan AE, Fifi JT, Zaidat OO. Aspiration thrombectomy with the Penumbra System for patients with stroke and late onset to treatment: a subset analysis of the COMPLETE registry. Front Neurol. 2023 Sep 14;14:1239640. doi: 10.3389/fneur.2023.1239640. eCollection 2023.
Hassan AE, Zaidat OO, Nanda A, Atchie B, Woodward K, Doerfler A, Tomasello A, Fifi JT. Impact of interhospital transfer vs. direct admission on acute ischemic stroke patients: A subset analysis of the COMPLETE registry. Front Neurol. 2022 Aug 9;13:896165. doi: 10.3389/fneur.2022.896165. eCollection 2022.
Zaidat OO, Fifi JT, Nanda A, Atchie B, Woodward K, Doerfler A, Tomasello A, Tekle W, Singh IP, Matouk C, Thalwitzer J, Jargiello T, Skrypnik D, Beuing O, Berge J, Katz JM, Biondi A, Bonovich D, Sheth SA, Yoo AJ, Hassan AE; COMPLETE Registry Investigators. Endovascular Treatment of Acute Ischemic Stroke With the Penumbra System in Routine Practice: COMPLETE Registry Results. Stroke. 2022 Mar;53(3):769-778. doi: 10.1161/STROKEAHA.121.034268. Epub 2021 Sep 22.
Other Identifiers
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12965
Identifier Type: -
Identifier Source: org_study_id