Stroke Thrombectomy and Aneurysm Registry

Stroke Clinical Trial

— STAR  

Official title:

Stroke Thrombectomy and Aneurysm Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04994756
• Other study ID #: Pro00090704
• Status: Recruiting
• Start date: September 17, 2019
• Est. completion date: January 1, 2055

Study information

• Verified date: November 2023
• Source: Medical University of South Carolina
• Contact: Alejandro M Spiotta, MD
• Phone: 843-792-9226
• Email: spiotta[@]musc.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This international multi-center registry is used to collect existing information and outcomes for patients undergoing an operation for treatment of injuries to the brain including the blockage of blood flow to an area of the brain, an abnormal ballooning of an artery, abnormal tangling of blood vessels, abnormal formation of blood vessels, tearing of vein, and bleeding in the brain. This information is used to help predict outcomes that undergo an operation for treatment of the above-listed brain injuries. Additionally, the information is used to compare techniques and devices' effects on technical and clinical outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40000
• Est. completion date: January 1, 2055
• Est. primary completion date: January 1, 2055
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 120 Years

Eligibility

Inclusion Criteria:

• Undergoing surgical intervention for central nervous system vascular lesion
• Between 1 and 120 years of age

Exclusion Criteria:

• No exclusion criteria

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Brain
• Intracranial Aneurysm
• Intracranial Thrombosis
• Stroke
• Thromboses, Intracranial
• Thrombosis

Intervention

Procedure:
• Stroke/Thrombectomy/Aneurysm-specific surgical procedures
Participants are retrospectively and/or prospectively entered into registry based on disease indication and respective surgical procedure.

Locations

Country	Name	City	State
Argentina	Sanatorio Guemes	Buenos Aires
Canada	University of Saskatchewan	Saskatoon
Egypt	Damietta Specialized Hospital	Damietta
Germany	Universitätsmedizin Göttingen	Göttingen
Japan	Hyogo College of Medicine	Hyogo
Korea, Republic of	Chonnam National University Hospital	Gwangju
Portugal	Centro Hospitalar Universitário de Lisboa Central	Lisbon
Spain	Hospital Universitario La Paz	Madrid
Switzerland	Universitätsspital Basel	Basel
United States	Albany Medical Center	Albany	New York
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	Piedmont Healthcare	Atlanta	Georgia
United States	Indiana University	Bloomington	Indiana
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Rush University	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	University of Illinois	Chicago	Illinois
United States	NorthShore University HealthSystem	Evanston	Illinois
United States	Washington Regional Medical Center	Fayetteville	Arkansas
United States	University of Florida	Gainesville	Florida
United States	The University of Texas Medical Branch at Galveston	Galveston	Texas
United States	Baylor College of Medicine	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	HCA Houston Healthcare Kingwood	Kingwood	Texas
United States	Loma Linda University	Loma Linda	California
United States	University of Louisville	Louisville	Kentucky
United States	University of Tennessee Health Science Center	Memphis	Tennessee
United States	University of Miami Health System	Miami	Florida
United States	West Virginia University	Morgantown	West Virginia
United States	Rutgers University	New Brunswick	New Jersey
United States	Yale University	New Haven	Connecticut
United States	Cornell University	New York	New York
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	Global Neurosciences Institute	Pennington	New Jersey
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Alleghany Hospital	Pittsburgh	Pennsylvania
United States	Texas Stroke Institute	Plano	Texas
United States	Portsmouth Regional Hospital	Portsmouth	New Hampshire
United States	University of North Carolina	Raleigh	North Carolina
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University in St. Louis	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	University of Washington	Seattle	Washington
United States	Louisiana State University Health Shreveport	Shreveport	Louisiana
United States	Stony Brook University	Stony Brook	New York
United States	University of South Florida	Tampa	Florida
United States	Mercy Health	Toledo	Ohio
United States	University of Arizona	Tucson	Arizona
United States	Geisinger Medical Group	Wilkes-Barre	Pennsylvania
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina
United States	University of Michigan Health-West	Wyoming	Michigan
United States	WellSpan York Hospital	York	Pennsylvania
Uruguay	Médica Uruguaya	Montevideo

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Countries where clinical trial is conducted

United States,  Uruguay,  Argentina,  Canada,  Egypt,  Germany,  Japan,  Korea, Republic of,  Portugal,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-procedure hemorrhage rate changes	Researchers examine changes in hemorrhage rates in post-stroke patients	90 days
Primary	Occlusion rates	Measure of how thrombectomy procedure success in relation to reduced occlusion	90 days
Primary	Complication rates	Measure of post-procedure complication rates in stroke/aneurysm patients	90 days
Primary	Retreatment rates	Measure of patient retreatment post-procedure	90 days