Ideal Sedation for Stroke Thrombectomy

Ischemic Stroke Clinical Trial

— ISST  

Official title:

Ideal Sedation for Stroke Thrombectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03036631
• Other study ID #: 20150455
• Status: Completed
• Start date: October 2016
• Est. completion date: April 2018

Study information

• Verified date: July 2018
• Source: Neurovascular Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
United States	Los Robles Hospital and Medical Center	Thousand Oaks	California

Sponsors (1)

Lead Sponsor	Collaborator
Dr. M. Asif Taqi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time interval between groin puncture and final recanalization		6 months or at study completion