STAR: Stroke Thrombectomy and Aneurysm Registry

Sponsor
Medical University of South Carolina (Other)
Overall Status
Recruiting
CT.gov ID
NCT04994756
Collaborator
(none)
40,000
22
423.5
1818.2
4.3

Study Details

Study Description

Brief Summary

This international multi-center registry will be 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 will be used to help predict outcomes that undergo operation for treatment of the above listed brain injuries. Additionally, the information will be used to compare techniques and devices' affect on technical and clinical outcomes.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Stroke/Thrombectomy/Aneurysm-specific surgical procedures

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
40000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Stroke Thrombectomy and Aneurysm Registry
Actual Study Start Date :
Sep 17, 2019
Anticipated Primary Completion Date :
Jan 1, 2055
Anticipated Study Completion Date :
Jan 1, 2055

Arms and Interventions

Arm Intervention/Treatment
Stroke

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

Thrombectomy

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

Aneurysm

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

Outcome Measures

Primary Outcome Measures

  1. Post-procedure hemorrhage rate changes [90 days]

    Researchers examine changes in hemorrhage rates in post-stroke patients

  2. Occlusion rates [90 days]

    Measure of how thrombectomy procedure success in relation to reduced occlusion

  3. Complication rates [90 days]

    Measure of post-procedure complication rates in stroke/aneurysm patients

  4. Retreatment rates [90 days]

    Measure of patient retreatment post-procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Undergoing surgical intervention for central nervous system vascular lesion

  • Between 1 and 120 years of age

Exclusion Criteria:
  • No exclusion criteria

Contacts and Locations

Locations

Site City State Country Postal Code
1 Barrow Neurological Institute Phoenix Arizona United States 85013
2 Arizona University Tucson Arizona United States 85721
3 University of Florida Gainesville Florida United States 32611
4 University of Miami Health System Miami Florida United States 33136
5 Rush University Chicago Illinois United States 60612
6 University of Iowa Iowa City Iowa United States 52242
7 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
8 Washington University in St. Louis Saint Louis Missouri United States 63110
9 Mount Sinai Health System New York New York United States 10019
10 Cornell University New York New York United States 10065
11 Wake Forest Baptist Health Winston-Salem North Carolina United States 27157
12 Thomas Jefferson University Philadelphia Pennsylvania United States 19107
13 Medical University of South Carolina Charleston South Carolina United States 29425
14 University of Tennessee Health Science Center Memphis Tennessee United States 38163
15 Baylor College of Medicine Houston Texas United States 77030
16 University of Virginia Charlottesville Virginia United States 22904
17 University of Washington Seattle Washington United States 98195
18 West Virginia University Morgantown West Virginia United States 26506
19 Argentina Buenos Aires Argentina
20 Universitätsmedizin Göttingen Göttingen Germany
21 Chonnam National University Hospital Gwangju Korea, Republic of
22 Médica Uruguaya Montevideo Uruguay

Sponsors and Collaborators

  • Medical University of South Carolina

Investigators

  • Study Director: Meredith Robinson, MS, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alejandro Spiotta, MD, Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT04994756
Other Study ID Numbers:
  • Pro00090704
First Posted:
Aug 6, 2021
Last Update Posted:
Aug 6, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 6, 2021