Registry of Emergent Large VeSsel OCclUsion DuE to IntraCranial AtherosclerosiS

NCT05403593 | Completed

• 1 other identifier: Pro00115854
• Study Type: observational
• Target: 600
• Locations: 6 countries
• Sites: 19

Brief Summary

The aim of this study is to develop an international multicenter registry of patient data and outcomes for patients undergoing mechanical thrombectomy for emergent large vessel occlusion with residual underlying stenosis following successful revascularization.

Conditions

Intracranial Stenosis; Large Vessel Occlusion; Mechanical Thrombectomy

Keywords

Intracranial Stenosis; Large Vessel Occlusion

Outcome Measures

Primary Outcomes (5)

• modified Rankin score

  standard stroke score measuring disability level delivered by physician with level 0-6 with 0 being no symptoms and 6 being death. Outcome measured by the distribution of mRS score.

  pre-stroke

• modified Rankin score

  standard stroke score measuring disability level delivered by physician with level 0-6 with 0 being no symptoms and 6 being death. Outcome measured by the distribution of mRS score.

  7 days

• modified Rankin score

  standard stroke score measuring disability level delivered by physician with level 0-6 with 0 being no symptoms and 6 being death. Outcome measured by the distribution of mRS score.

  admission

• modified Rankin score

  standard stroke score measuring disability level delivered by physician with level 0-6 with 0 being no symptoms and 6 being death. Outcome measured by the distribution of mRS score.

  3 months

• Mortality

  Death at 90 days post intervention

  90 day

Study Arms (1)

Participants with Intracranial Stenosis

Patients with Intracranial Stenosis who undergo Mechanical Thrombectomy will be added to the registry given they meet the age inclusion criteria.

Other: No Intervention

Interventions

No Intervention OTHER

No intervention, prospective data collection

Participants with Intracranial Stenosis

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects aged 18-90 years will be identified once they undergo mechanical thrombectomy and identified as having intracranial stenosis as the etiology for large vessel occlusion.

You may qualify if:

• All patients undergoing mechanical thrombectomy
• AND have intracranial stenosis
• Patients aged 18-90 years

You may not qualify if:

• None

Sponsors & Collaborators

• Medical University of South Carolina: lead
• University of Göttingen: collaborator
• Thomas Jefferson University: collaborator
• University of Miami: collaborator
• University of Basel: collaborator
• University of Tennessee: collaborator
• Wake Forest University Health Sciences: collaborator
• Emory University: collaborator
• The University of Texas Health Science Center at San Antonio: collaborator
• University of Iowa: collaborator
• Indiana University: collaborator
• University of Chicago: collaborator
• Careggi Hospital: collaborator
• Massachusetts General Hospital: collaborator
• Imam Abdulrahman Bin Faisal University: collaborator
• Brown University: collaborator
• Yale University: collaborator
• Sutter Health: collaborator
• Centro Hospitalar de Lisboa Central: collaborator
• HCA Houston Healthcare Kingwood: collaborator
• advocate christ medical center: collaborator

Study Sites (19)

Yale New Haven Hospital

New Haven, Connecticut, 06508, United States

Location

Univeristy of Miami Health System

Miami, Florida, 33136, United States

Location

Emory Univeristy Hospital

Atlanta, Georgia, 30322, United States

Location

Univeristy of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Advocate Aurora Health

Oak Lawn, Illinois, 60453, United States

Location

Indiana Health Univeristy Hospital

Indianapolis, Indiana, 46202, United States

Location

Univeristy of Iowa Hospital

Iowa City, Iowa, 52242, United States

Location

Massachuestts General Hospital

Boston, Massachusetts, 02114, United States

Location

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Brown University

Providence, Rhode Island, 02903, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

The University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

Univeristy of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Universitätsmedizin Göttingen

Göttingen, Germany, 37099, Germany

Location

Careggi Universtiy Hospital

Florence, Florence, 50134, Italy

Location

Nova University Lisbon

Lisbon, Portugal, 1169-056, Portugal

Location

Imam Abdulrahman Alfaisal University

Dammam, Dammam, 34212, Saudi Arabia

Location

Universitätsspital Basel

Basel, Basel, 4031, Switzerland

Location

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Study Officials

• Sami Al Kasab, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 3, 2022
• Study Start: December 15, 2021
• Primary Completion: March 5, 2024
• Study Completion: June 14, 2024
• Last Updated: September 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); PT (1); IT (1); SA (1); DE (1); US (14)