Trials / Completed
CompletedNCT03804060
REperfusion With Cooling in CerebraL Acute IscheMia II
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 90 (actual)
- Sponsor
- ZOLL Circulation, Inc., USA · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2019-05-23
- Primary completion
- 2024-05-01
- Completion
- 2024-05-01
- First posted
- 2019-01-15
- Last updated
- 2024-05-16
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03804060. Inclusion in this directory is not an endorsement.