Clinical trial NCT03464565: COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device
Official title: COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Ischemic
Keywords: Large Vessel Occlusion
Acute Ischemic Stroke
Mechanical Thrombectomy
Penumbra System
3D Revascularization
Lead sponsor: Penumbra Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-14
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients experiencing acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy using the Penumbra System

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).

Detailed description: Registry Objective: The primary objective of this registry is to collect real-world performance and safety data on Penumbra System including the 3D Revascularization Device in a patient population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: mTICI Score
timeFrame: Post Procedure
measure: Functional Subject Outcome
timeFrame: 90 days post
measure: All-cause mortality at 90 days
timeFrame: 90 days
Secondary outcomes:
measure: Incidence of device and procedure related Serious Adverse Events (SAEs)
timeFrame: Within 24 hours of procedure
measure: Occurrence of embolization in previously uninvolved (or new) territories (ENT)
timeFrame: During Procedure
measure: Occurrence of symptomatic intracranial hemorrhages (sICH)
timeFrame: 24 Hours Post Procedure
measure: Time to Revascularization
timeFrame: During Procedure
measure: Length of hospital stay
timeFrame: Through discharge, up to study completion at approximately 90 days
measure: Discharge Facility
timeFrame: Through discharge, up to study completion at approximately 90 days
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Banner Desert Medical Center
state: Arizona
city: Castro Valley
country: United States
facility: Eden Medical Center
state: California
city: Fullerton
country: United States
facility: St. Jude Medical Center
state: California
city: Los Angeles
country: United States
facility: Cedar Sinai Medical Center
state: California
city: Sacramento
country: United States
facility: Mercy San Juan Medical Center
state: California
city: Thousand Oaks
country: United States
facility: Los Robles Hospital
state: California
city: Englewood
country: United States
facility: RIA
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Naples
country: United States
facility: Naples Community Hospital
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: New Orleans
country: United States
facility: Oschner Medical Center
state: Louisiana
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: SSM St. Clare Healthcare
state: Missouri
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: Mount Sinai New York
state: New York
city: New York
country: United States
facility: NYU Langone Hospital-Brooklyn
state: New York
city: Toledo
country: United States
facility: Mercy St. Vincent Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Columbia
country: United States
facility: Palmetto Health Richland Hospital
state: South Carolina
city: Chattanooga
country: United States
facility: Erlanger Health System
state: Tennessee
city: Knoxville
country: United States
facility: Fort Sanders Regional Medical Center
state: Tennessee
city: Memphis
country: United States
facility: Methodist University Hospital
state: Tennessee
city: Harlingen
country: United States
facility: Valley Baptist Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: McAllen
country: United States
facility: McAllen Medical Center
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center-Cherry Hill
state: Washington
city: Bordeaux
country: France
facility: CHU de Bordeaux - Hôpital Pellegrin
city: Paris
country: France
facility: Foundation Ophthalmic Adolphe De Rothschild
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg A. ö. R.
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny
city: Moscow
country: Russian Federation
facility: Davidovsky Moscow City Hospital №23
city: Moscow
country: Russian Federation
facility: City Clinical Hospital No. 1
city: Saint Petersburg
country: Russian Federation
facility: Multidisciplinary City Hospital №2
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
Study officials:
affiliation: Mercy St. Vincent Medical Center
name: Osama O Zaidat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mount Sinai Health System
name: Johanna Fifi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McAllen Medical Center
name: Ameer E. Hassan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.