REperfusion With Cooling in CerebraL Acute IscheMia II

Not Applicable

Completed

• Conditions: Ischemic Stroke
• Interventions: Device: Thermogard XP3; Procedure: Recanalization only

• Registration Number: NCT03804060
• Lead Sponsor: ZOLL Circulation, Inc., USA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-09
• Study First Submitted QC: 2019-01-11
• Study First Posted: 2019-01-15
• Study Start: 2019-05-23
• Status Verified: 2024-05
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cooling + Recanalization	Thermogard XP3	The subjects will be considered to be enrolled in the Test Arm of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the Test Arm of the trial to allow cooling with the Thermogard XP3 IVTM System before and after recanalization.
Recanalization only	Recanalization only	The subjects will be considered to be enrolled in the Control Arm of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the Control Arm of the trial to allow recanalization only.

Primary Outcome Measures

Name	Time	Method
Percentage of Test Arm patients achieving target temperature	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	36 hours	Rate of hemorrhagic conversion
Mean door-to-Recanalization time	perioperative	door-to-Recanalization time

Trial Locations

Locations (8)

WellStar Kennestone Regional Medical Center; 🇺🇸 Marietta, Georgia, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States

Henry Ford; 🇺🇸 Detroit, Michigan, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

The Queen's Medical Center; 🇺🇸 Honolulu, Hawaii, United States

ProMedica Toledo Hospital; 🇺🇸 Toledo, Ohio, United States

Mercy Health; 🇺🇸 Toledo, Ohio, United States