NCT03036631

Brief Summary

The Ideal Sedation for Stroke Thrombectomy (ISST) registry will answer the key questions whether sedation with intubation and paralytics is feasible and whether it delays the time to recanalization in comparison with conscious sedation alone. As a pilot registry, it is anticipated to enroll 40 acute stroke patients requiring mechanical thrombectomy over 12-18 months. Following enrollment, data will be collected prospectively from medical records and from patients' visits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2016

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

Study Start

First participant enrolled

October 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 30, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

July 19, 2018

Status Verified

July 1, 2018

Enrollment Period

1.4 years

First QC Date

December 28, 2016

Last Update Submit

July 17, 2018

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • Time interval between groin puncture and final recanalization

    6 months or at study completion

Study Arms (2)

Conscious Sedation/Monitored Anesthesia Care

General Anesthesia

Eligibility Criteria

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

Patients underwent mechanical thrombectomy at Los Robles hospital, Thousand Oaks, CA

You may qualify if:

  • Age ≥ 18 years
  • Suitable for intra-arterial treatment for acute stroke up to 8 hours from onset of symptoms
  • Clinical equipoise for best mode of sedation

You may not qualify if:

  • Any known allergy to either proposed medication and its alternative
  • Any patient that has been intubated prior to randomization
  • Posterior circulation strokes
  • Age ≤ 18
  • Pregnant female

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Los Robles Hospital and Medical Center

Thousand Oaks, California, 91360, United States

Location

Related Publications (1)

  • Taqi MA, Suriya SS, Sodhi A, Quadri SA, Farooqui M, Zafar A, Mortazavi MM. Ideal sedation for stroke thrombectomy: a prospective pilot single-center observational study. Neurosurg Focus. 2019 Feb 1;46(2):E16. doi: 10.3171/2018.11.FOCUS18522.

    PMID: 30717046DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Muhammad A Taqi

    Neurovascular Research Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director Neuroendovascular

Study Record Dates

First Submitted

December 28, 2016

First Posted

January 30, 2017

Study Start

October 1, 2016

Primary Completion

March 1, 2018

Study Completion

April 1, 2018

Last Updated

July 19, 2018

Record last verified: 2018-07

Locations

US(1)