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Stroke Thrombectomy and Aneurysm Registry (STAR)

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ClinicalTrials.gov Identifier: NCT04994756
Recruitment Status : Recruiting
First Posted : August 6, 2021
Last Update Posted : October 5, 2022
Sponsor:
Information provided by (Responsible Party):
Alejandro Spiotta, MD, Medical University of South Carolina

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Stroke Thromboses, Intracranial Aneurysm, Brain Procedure: Stroke/Thrombectomy/Aneurysm-specific surgical procedures

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 40000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 90 Days
Official Title: Stroke Thrombectomy and Aneurysm Registry
Actual Study Start Date : September 17, 2019
Estimated Primary Completion Date : January 1, 2055
Estimated Study Completion Date : January 1, 2055

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Post-procedure hemorrhage rate changes [ Time Frame: 90 days ]
    Researchers examine changes in hemorrhage rates in post-stroke patients

  2. Occlusion rates [ Time Frame: 90 days ]
    Measure of how thrombectomy procedure success in relation to reduced occlusion

  3. Complication rates [ Time Frame: 90 days ]
    Measure of post-procedure complication rates in stroke/aneurysm patients

  4. Retreatment rates [ Time Frame: 90 days ]
    Measure of patient retreatment post-procedure


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patients between 1 and 120 years of age, undergoing surgical intervention for central nervous system vascular lesions.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04994756


Contacts
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Contact: Alejandro M Spiotta, MD 843-792-9226 spiotta@musc.edu
Contact: Anna M Bisig, MS 843-792-4601 bisig@musc.edu

Locations
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Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Study Director: Meredith Robinson, MS Medical University of South Carolina
More Information
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Responsible Party: Alejandro Spiotta, MD, Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT04994756    
Other Study ID Numbers: Pro00090704
First Posted: August 6, 2021    Key Record Dates
Last Update Posted: October 5, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Intracranial Aneurysm
Intracranial Thrombosis
Aneurysm
Thrombosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Embolism and Thrombosis
Intracranial Arterial Diseases
Intracranial Embolism and Thrombosis
Thromboembolism