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

Stroke, Ischemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03464565
• Other study ID #: 12965
• Status: Completed
• Start date: July 2, 2018
• Est. completion date: January 17, 2020

Study information

• Verified date: December 2020
• Source: Penumbra Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: January 17, 2020
• Est. primary completion date: January 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Stroke
• Stroke, Ischemic

Intervention

Device:
• Penumbra System
Penumbra System

Locations

Country	Name	City	State
France	CHU de Bordeaux - Hôpital Pellegrin	Bordeaux
France	Foundation Ophthalmic Adolphe De Rothschild	Paris
Germany	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
Poland	Samodzielny Publiczny Szpital Kliniczny	Lublin
Russian Federation	City Clinical Hospital No. 1	Moscow
Russian Federation	Davidovsky Moscow City Hospital ?23	Moscow
Russian Federation	Multidisciplinary City Hospital ?2	Saint Petersburg
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	Murcia
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Eden Medical Center	Castro Valley	California
United States	Erlanger Health System	Chattanooga	Tennessee
United States	Palmetto Health Richland Hospital	Columbia	South Carolina
United States	RIA	Englewood	Colorado
United States	St. Jude Medical Center	Fullerton	California
United States	Valley Baptist Medical Center	Harlingen	Texas
United States	Houston Methodist Hospital	Houston	Texas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Fort Sanders Regional Medical Center	Knoxville	Tennessee
United States	Cedar Sinai Medical Center	Los Angeles	California
United States	Northwell Health	Manhasset	New York
United States	McAllen Medical Center	McAllen	Texas
United States	Methodist University Hospital	Memphis	Tennessee
United States	Banner Desert Medical Center	Mesa	Arizona
United States	Jackson Memorial Hospital	Miami	Florida
United States	Naples Community Hospital	Naples	Florida
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Oschner Medical Center	New Orleans	Louisiana
United States	Mount Sinai New York	New York	New York
United States	NYU Langone Hospital-Brooklyn	New York	New York
United States	AdventHealth Orlando	Orlando	Florida
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	The Valley Hospital	Ridgewood	New Jersey
United States	Mercy San Juan Medical Center	Sacramento	California
United States	SSM St. Clare Healthcare	Saint Louis	Missouri
United States	Swedish Medical Center-Cherry Hill	Seattle	Washington
United States	Los Robles Hospital	Thousand Oaks	California
United States	Mercy St. Vincent Medical Center	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Penumbra Inc.

Countries where clinical trial is conducted

United States,  France,  Germany,  Poland,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	All-cause mortality at 90 days	All-cause mortality at 90 days	90 days
Secondary	Incidence of device and procedure related Serious Adverse Events (SAEs)		Within 24 hours of procedure
Secondary	Occurrence of embolization in previously uninvolved (or new) territories (ENT)	Occurrence of embolization in previously uninvolved (or new) territories (ENT) as seen on the final control angiogram at the end of procedure	During Procedure
Secondary	Occurrence of symptomatic intracranial hemorrhages (sICH)		24 Hours Post Procedure
Secondary	Time to Revascularization		During Procedure
Secondary	Length of hospital stay		Through discharge, up to study completion at approximately 90 days
Secondary	Discharge Facility		Through discharge, up to study completion at approximately 90 days