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Ideal Sedation for Stroke Thrombectomy (ISST)

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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

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.

Condition or disease
Ischemic Stroke

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Study Type : Observational [Patient Registry]
Actual Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Ideal Sedation for Stroke Thrombectomy
Study Start Date : October 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : April 2018

Group/Cohort
Conscious Sedation/Monitored Anesthesia Care
General Anesthesia



Primary Outcome Measures :
  1. Time interval between groin puncture and final recanalization [ Time Frame: 6 months or at study completion ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients underwent mechanical thrombectomy at Los Robles hospital, Thousand Oaks, CA
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

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): NCT03036631


Locations
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United States, California
Los Robles Hospital and Medical Center
Thousand Oaks, California, United States, 91360
Sponsors and Collaborators
Dr. M. Asif Taqi
Investigators
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Principal Investigator: Muhammad A Taqi Neurovascular Research Foundation

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. M. Asif Taqi, Director Neuroendovascular, Neurovascular Research Foundation
ClinicalTrials.gov Identifier: NCT03036631     History of Changes
Other Study ID Numbers: 20150455
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases