NCT03632902

Brief Summary

Endovascular techniques for the treatment of intracranial aneurysms are growing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

June 26, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2019

Completed
Last Updated

May 28, 2020

Status Verified

May 1, 2020

Enrollment Period

1.3 years

First QC Date

June 26, 2018

Last Update Submit

May 27, 2020

Conditions

Airway Management

Keywords

supraglottic devices

Outcome Measures

Primary Outcomes (1)

  • Security in the use of supraglottic devices in the unruptured intracranial aneurysms.

    security; the incidence of adverse events during the procedure and post-procedure will be recorded, also morbidity and mortality in patients managed with supraglottic devices during unruptured aneurysm embolization

    ten years

Interventions

supraglottic deviceDEVICE

airway management will be collected

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent endovascular treatment for unruptured aneurysm in the past 8 years in our institution

You may qualify if:

  • patients that underwent endovascular treatment for unruptured aneurysm

You may not qualify if:

  • ruptured aneurysm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic

Barcelona, Catalonia, 08019, Spain

Location

Study Officials

  • PAOLA A HURTADO RESTREPO, md

    anesthesiologist in Hospital Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of neuroanesthesia section

Study Record Dates

First Submitted

June 26, 2018

First Posted

August 16, 2018

Study Start

June 26, 2018

Primary Completion

October 20, 2019

Study Completion

November 20, 2019

Last Updated

May 28, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)