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REperfusion With Cooling in CerebraL Acute IscheMia II

NCT03804060 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-05-16

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Thermogard XP3

Cooling with the ZOLL® Circulation catheter and the ZOLL® Intravascular Temperature Management system to initiate and maintain hypothermia for 6 hours as an adjunct to endovascular Recanalization.

PROCEDURE

Recanalization only

Standard of Care for recanalization

Sponsors & Collaborators

  • ZOLL Circulation, Inc., USA

    lead INDUSTRY

Principal Investigators

  • Rishi Gupta, MD, MBA · Wellstar Medical Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-23
Primary Completion
2024-05-01
Completion
2024-05-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03804060 on ClinicalTrials.gov