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Clinical Trials/NCT03804060
NCT03804060
Completed
N/A

A Multicenter, Prospective, Randomized-controlled Trial to Assess the Safety and Feasibility of Cooling as an Adjunctive Therapy to Thrombectomy and Reperfusion in Patients With Acute Cerebral Ischemia and Stroke

ZOLL Circulation, Inc., USA8 sites in 1 country90 target enrollmentMay 23, 2019
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ConditionsIschemic Stroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Ischemic Stroke
Sponsor
ZOLL Circulation, Inc., USA
Enrollment
90
Locations
8
Primary Endpoint
Percentage of Test Arm patients achieving target temperature
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The primary objective of this study is to determine the feasibility and safety of achieving rapid hypothermia with the Proteus Intravascular Temperature Management (IVTM) system for patients experiencing acute ischemic stroke due to a large vessel occlusion.

Registry
clinicaltrials.gov
Start Date
May 23, 2019
End Date
May 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
ZOLL Circulation, Inc., USA
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Percentage of Test Arm patients achieving target temperature

Time Frame: 1 hour after thrombectomy

Percentage of Test Arm patients achieving target temperature \< 34 ºC within 1 hour of arterial puncture for thrombectomy

Rate of hemorrhagic conversion in each arm within 36 hours of Recanalization

Time Frame: 36 hours

Rate of hemorrhagic conversion

Mean door-to-Recanalization time

Time Frame: perioperative

door-to-Recanalization time

Study Sites (8)

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