REperfusion With Cooling in CerebraL Acute IscheMia II (RECCLAIM-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

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke
• Intervention / Treatment: Device: Thermogard XP3; Procedure: Recanalization only

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Wellstar Kennestone Regional Medical Center
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • The Queen's Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford
  • Ohio
    • Toledo, Ohio, United States, 43606
      • ProMedica Toledo Hospital
    • Toledo, Ohio, United States, 43608
      • Mercy Health
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

All Inclusion Criteria must be answered YES for Patient to be eligible.

1. Age ≥18 and ≤85;
2. 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);
3. Ability to perform arterial puncture within 24 hours from symptom onset or LKN;
4. ASPECTS score of 6-10 on non-contrast CT of the brain if under 80 years; ASPECTS 9-10 if age 80-85;
5. 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
6. Candidate for endovascular thrombectomy therapy in accordance with best practices per AHA standard stroke guidelines meeting all labeling requirements for EVT in the trial;
7. No contraindications to general anesthesia, conscious sedation or allergies to any components associated with the anticipated diagnostic or treatment procedures that cannot be treated;
8. A pre-stroke modified Rankin Score (mRS) of 0 or 1 (Appendix 4);
9. Baseline CT scan shows no hemorrhage;
10. NIHSS greater than or equal to 8 (Appendix 3);
11. Patient is capable of complying with study procedures and agrees to complete all required study procedures, study visits and associated activities;
12. 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.

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.

1. Age ≥18 and ≤85;
2. 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);
3. Ability to perform arterial puncture within 24 hours from symptom onset or LKN;
4. ASPECT score of 6-10 on non-contrast CT of the brain if under 80 years; ASPECTS 9-10 if age 80-85;
5. 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;
6. Candidate for endovascular thrombectomy therapy in accordance with best practices per AHA standard stroke guidelines meeting all labeling requirements for EVT in the trial;
7. No contraindications to general anesthesia, conscious sedation or allergies to any components associated with the anticipated diagnostic or treatment procedures that cannot be treated;
8. A pre-stroke mRS of 0 or 1 (Appendix 4);
9. Baseline CT scan shows no hemorrhage;
10. NIHSS greater than or equal to 8 (Appendix 3);
11. Patient is capable of complying with study procedures and agrees to complete all required study procedures, study visits and associated activities;
12. 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.

Exclusion Criteria All Exclusion Criteria must be answered NO to be eligible.

1. Patient arrives to the enrolling hospital intubated
2. Female patients of childbearing potential who are known to be or may be pregnant;
3. 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
4. The patient has a height of < 1.5 meters (4 feet 11 inches);
5. Use of warfarin with INR > 1.7;
6. Blood clinical chemistry potassium (K+) < 2.7;
7. History of severe dementia and currently taking medication for cognitive impairment or behavior disorder;
8. End stage renal disease on hemodialysis;
9. Known presence of an IVC filter;
10. Contrast dye allergy with history of anaphylaxis, known serious sensitivity to contrast agents or any condition in which angiography is contraindicated;
11. Known to have contraindications to radiological imaging;
12. Known allergy to meperidine or buspar or dexmedetomidine;
13. Sustained hypertension (SBP > 185 or DBP > 110 unable to be treated with a continuous infusion, e.g., nicardipine);
14. Baseline CT/MR showing evidence of arterial vasculitis or dissection;
15. Baseline CT/MR evidence of multiple vascular territory acute stroke;
16. Excessive tortuosity of cervical vessels;
17. Intracranial stent in area that may impact Recanalization;
18. Presence of Pulmonary embolism, ilio-femoral or deep vein thrombosis
19. Presence of clinical signs of sepsis
20. Ongoing or spontaneous atrial fibrillation indicating severe peripheral vascular disease, aortic disease, or proximal cerebrovascular disease that in the opinion of the investigator precludes access or safe endovascular treatment
21. Presence of any other serious comorbidity that would be likely to impact life expectancy to less than 6 months or limit Patient cooperation or study compliance
22. Concurrent participation in an investigational clinical study (excluding registries) that has not completed the follow-up period or planned participation in another study within the next 3 months;
23. Patient has any other condition(s) or circumstance(s) that, in the judgement of the investigator, might interfere with or impact the collection of high quality data, or with the completion of follow up requirements within the study windows.
24. Patient has active or symptomatic COVID-19
25. Patients without a legally authorized representative to sign the consent form will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cooling + Recanalization; 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; 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.
Active Comparator: 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.	Procedure: Recanalization only; Standard of Care for recanalization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: ZOLL Circulation, Inc., USA
• Investigators: Principal Investigator: Rishi Gupta, MD, MBA, WellStar Medical Group

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2019
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: January 11, 2019
• First Posted (Actual): January 15, 2019

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Stroke; Cooling; Therapeutic Hypothermia; Neurological Acute Care
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia
• Other Study ID Numbers: EDC-3599

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes