Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cooling + Recanalization | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermogard XP3 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Test Arm patients achieving target temperature | Percentage of Test Arm patients achieving target temperature < 34 ºC within 1 hour of arterial puncture for thrombectomy | 1 hour after thrombectomy |
| Mean door-to-Recanalization time | door-to-Recanalization time | perioperative |
| Rate of hemorrhagic conversion in each arm within 36 hours of Recanalization | Rate of hemorrhagic conversion | 36 hours |
Not provided
Not provided
All Inclusion Criteria must be answered YES for Patient to be eligible.
5.2 Exclusion Criteria In order to be eligible for participation, patients must meet all Inclusion and Exclusion Criteria.
Inclusion Criteria All Inclusion Criteria must be answered YES for Patient to be eligible.
Exclusion Criteria All Exclusion Criteria must be answered NO to be eligible.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rishi Gupta, MD, MBA | Wellstar Medical Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WellStar Kennestone Regional Medical Center | Marietta | Georgia | 30060 | United States | ||
| The Queen's Medical Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 8, 2026 | Apr 28, 2026 | 11 | ||
| May 19, 2026 |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Recanalization only | Procedure | Standard of Care for recanalization |
|
| Honolulu |
| Hawaii |
| 96813 |
| United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Henry Ford | Detroit | Michigan | 48202 | United States |
| ProMedica Toledo Hospital | Toledo | Ohio | 43606 | United States |
| Mercy Health | Toledo | Ohio | 43608 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Jun 15, 2026 |
| 12 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |