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Ideal Sedation for Stroke Thrombectomy (ISST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03036631
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. M. Asif Taqi, Neurovascular Research Foundation

Tracking Information
First Submitted Date December 28, 2016
First Posted Date January 30, 2017
Last Update Posted Date July 19, 2018
Study Start Date October 2016
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 25, 2017)
Time interval between groin puncture and final recanalization [ Time Frame: 6 months or at study completion ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ideal Sedation for Stroke Thrombectomy
Official Title Ideal Sedation for Stroke Thrombectomy
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 3 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients underwent mechanical thrombectomy at Los Robles hospital, Thousand Oaks, CA
Condition Ischemic Stroke
Intervention Not Provided
Study Groups/Cohorts
  • Conscious Sedation/Monitored Anesthesia Care
  • General Anesthesia
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 25, 2017)
40
Original Estimated Enrollment Same as current
Actual Study Completion Date April 2018
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03036631
Other Study ID Numbers 20150455
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. M. Asif Taqi, Neurovascular Research Foundation
Study Sponsor Dr. M. Asif Taqi
Collaborators Not Provided
Investigators
Principal Investigator: Muhammad A Taqi Neurovascular Research Foundation
PRS Account Neurovascular Research Foundation
Verification Date July 2018