REperfusion With Cooling in CerebraL Acute IscheMia II

NCT03804060 | Completed DMC FDA Device

• 1 other identifier: EDC-3599
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 8

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.

Conditions

Ischemic Stroke

Keywords

Therapeutic Hypothermia; Cooling; Stroke; Neurological Acute Care

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

Device: Thermogard XP3

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.

Procedure: Recanalization only

Interventions

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.

Cooling + Recanalization

Recanalization only PROCEDURE

Standard of Care for recanalization

Recanalization only

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 and ≤85;
• Signs and symptoms consistent with an acute ischemic stroke with anterior circulation large vessel occlusion (M1 MCA, carotid-terminus occlusion, Tandem occlusion allowed (Extracranial ICA+carotid T or M1 MCA)) as determined by CT imaging; (i.e., hyperdense sign on non-contrast CT or CT angiogram);
• Ability to perform arterial puncture within 24 hours from symptom onset or LKN;
• ASPECTS score of 6-10 on non-contrast CT of the brain if under 80 years; ASPECTS 9-10 if age 80-85;
• For transfer patients with anticipated arterial puncture greater than 6 hours from symptom onset or LKN, qualifying imaging must be performed within 2 hours prior to enrolling hospital arrival; or with a newly obtained non-contrast CT scan if this time is exceeded
• Candidate for endovascular thrombectomy therapy in accordance with best practices per AHA standard stroke guidelines meeting all labeling requirements for EVT in the trial;
• No contraindications to general anesthesia, conscious sedation or allergies to any components associated with the anticipated diagnostic or treatment procedures that cannot be treated;
• A pre-stroke modified Rankin Score (mRS) of 0 or 1 (Appendix 4);
• Baseline CT scan shows no hemorrhage;
• NIHSS greater than or equal to 8 (Appendix 3);
• Patient is capable of complying with study procedures and agrees to complete all required study procedures, study visits and associated activities;
• Legally authorized representative must be able to understand and give written informed consent. Patient will assent if capable. Patient may be re-consented once it is established that there is no memory loss or cognitive impairment.

You may not qualify if:

• Age ≥18 and ≤85;
• Signs and symptoms consistent with an acute ischemic stroke with anterior circulation large vessel occlusion (M1 MCA, carotid-terminus occlusion, Tandem occlusion allowed (Extracranial ICA+carotid T or M1 MCA)) as determined by CT imaging; (i.e., hyper dense sign on non-contrast CT or CT angiogram);
• Ability to perform arterial puncture within 24 hours from symptom onset or LKN;
• ASPECT score of 6-10 on non-contrast CT of the brain if under 80 years; ASPECTS 9-10 if age 80-85;
• For transfer patients with anticipated arterial puncture greater than 6 hours from symptom onset or LKN, qualifying imaging must be performed within 2 hours prior to enrolling hospital arrival or with a newly obtained non-contrast CT scan if this time is exceeded;
• Candidate for endovascular thrombectomy therapy in accordance with best practices per AHA standard stroke guidelines meeting all labeling requirements for EVT in the trial;
• No contraindications to general anesthesia, conscious sedation or allergies to any components associated with the anticipated diagnostic or treatment procedures that cannot be treated;
• A pre-stroke mRS of 0 or 1 (Appendix 4);
• Baseline CT scan shows no hemorrhage;
• NIHSS greater than or equal to 8 (Appendix 3);
• Patient is capable of complying with study procedures and agrees to complete all required study procedures, study visits and associated activities;
• Legally authorized representative must be able to understand and give written informed consent. Patient will assent if capable. Patient may be re-consented once it is established that there is no memory loss or cognitive impairment.
• Patient arrives to the enrolling hospital intubated
• Female patients of childbearing potential who are known to be or may be pregnant;
• The patient has a known history of bleeding diathesis, coagulopathy, cryoglobulinemia, sickle cell anemia, will refuse blood transfusions or contraindication to heparin; history of genetically confirmed hypercoagulable syndrome

Sponsors & Collaborators

• ZOLL Circulation, Inc., USA: lead

Study Sites (8)

WellStar Kennestone Regional Medical Center

Marietta, Georgia, 30060, United States

Location

The Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Henry Ford

Detroit, Michigan, 48202, United States

Location

ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

Location

Mercy Health

Toledo, Ohio, 43608, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Rishi Gupta, MD, MBA

  Wellstar Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 15, 2019
• Study Start: May 23, 2019
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)