COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device
1 other identifier
observational
650
6 countries
42
Brief Summary
The purpose of this registry is to collect performance and safety data on the Penumbra System including the 3D Revascularization Device in a real world patient population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2018
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2018
CompletedFirst Posted
Study publicly available on registry
March 14, 2018
CompletedStudy Start
First participant enrolled
July 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2020
CompletedDecember 22, 2020
December 1, 2020
1.5 years
March 7, 2018
December 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
mTICI Score
Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a modified treatment in cerebral infarction (mTICI) score 2b or higher. mTICI scale ranges 0 to 3 higher values represent better outcomes.
Post Procedure
Functional Subject Outcome
Functional subject outcome at 90 days post-procedure as defined by a modified Rankin Scale (mRS) 0-2. mRS scale ranges 0 to 6 higher values represent a worse outcome.
90 days post
All-cause mortality at 90 days
All-cause mortality at 90 days
90 days
Secondary Outcomes (6)
Incidence of device and procedure related Serious Adverse Events (SAEs)
Within 24 hours of procedure
Occurrence of embolization in previously uninvolved (or new) territories (ENT)
During Procedure
Occurrence of symptomatic intracranial hemorrhages (sICH)
24 Hours Post Procedure
Time to Revascularization
During Procedure
Length of hospital stay
Through discharge, up to study completion at approximately 90 days
- +1 more secondary outcomes
Study Arms (1)
Patients with acute ischemic stroke secondary to LVO
Interventions
Eligibility Criteria
Patients experiencing acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy using the Penumbra System
You may qualify if:
- Patient age ≥ 18
- 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
You may not qualify if:
- Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 90 days.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Penumbra Inc.lead
Study Sites (42)
Banner Desert Medical Center
Mesa, Arizona, 85202, United States
Eden Medical Center
Castro Valley, California, 94546, United States
St. Jude Medical Center
Fullerton, California, 92835, United States
Cedar Sinai Medical Center
Los Angeles, California, 90048, United States
Mercy San Juan Medical Center
Sacramento, California, 95608, United States
Los Robles Hospital
Thousand Oaks, California, 91360, United States
RIA
Englewood, Colorado, 80112, United States
Yale New Haven Hospital
New Haven, Connecticut, 06519, United States
Jackson Memorial Hospital
Miami, Florida, 33136, United States
Naples Community Hospital
Naples, Florida, 34102, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
University of Kansas Medical Center
Kansas City, Kansas, 66106, United States
Oschner Medical Center
New Orleans, Louisiana, 70121, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
SSM St. Clare Healthcare
St Louis, Missouri, 63026, United States
The Valley Hospital
Ridgewood, New Jersey, 07450, United States
Northwell Health
Manhasset, New York, 11042, United States
Mount Sinai New York
New York, New York, 10029, United States
NYU Langone Hospital-Brooklyn
New York, New York, 11220, United States
Mercy St. Vincent Medical Center
Toledo, Ohio, 43608, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Palmetto Health Richland Hospital
Columbia, South Carolina, 29203, United States
Erlanger Health System
Chattanooga, Tennessee, 37403, United States
Fort Sanders Regional Medical Center
Knoxville, Tennessee, 37916, United States
Methodist University Hospital
Memphis, Tennessee, 38104, United States
Valley Baptist Medical Center
Harlingen, Texas, 78550, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
McAllen Medical Center
McAllen, Texas, 78503, United States
Swedish Medical Center-Cherry Hill
Seattle, Washington, 98122, United States
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, 33000, France
Foundation Ophthalmic Adolphe De Rothschild
Paris, 75019, France
Charité - Universitätsmedizin Berlin
Berlin, 10117, Germany
Klinikum Chemnitz gGmbH
Chemnitz, 09116, Germany
Universitätsklinikum Erlangen
Erlangen, 91054, Germany
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Lübeck, 23538, Germany
Universitätsklinikum Magdeburg A. ö. R.
Magdeburg, 39120, Germany
Samodzielny Publiczny Szpital Kliniczny
Lublin, 20 - 954, Poland
Davidovsky Moscow City Hospital №23
Moscow, 109240, Russia
City Clinical Hospital No. 1
Moscow, 119049, Russia
Multidisciplinary City Hospital №2
Saint Petersburg, 194354, Russia
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, 30120, Spain
Related Publications (3)
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.
PMID: 37794880DERIVEDHassan 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.
PMID: 36016541DERIVEDZaidat 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.
PMID: 34547927DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Osama O Zaidat, MD
Mercy St. Vincent Medical Center
- PRINCIPAL INVESTIGATOR
Johanna Fifi, MD
Mount Sinai Health System
- PRINCIPAL INVESTIGATOR
Ameer E. Hassan, MD
McAllen Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2018
First Posted
March 14, 2018
Study Start
July 2, 2018
Primary Completion
January 17, 2020
Study Completion
January 17, 2020
Last Updated
December 22, 2020
Record last verified: 2020-12