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Ischemic StrokeRECCLAIM-IINCT03804060

REperfusion With Cooling in CerebraL Acute IscheMia II

A study testing Thermogard XP3 and Recanalization only in people with Ischemic Stroke, run by ZOLL Circulation, Inc., USA at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Ischemic Stroke
What is being tested?
Thermogard XP3 and Recanalization only
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
8 sitesUnited States
Study dates
23 May 2019to 1 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites
  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Henry Ford

    Detroit, Michigan, 48202

  • The Queen's Medical Center

    Honolulu, Hawaii, 96813

  • WellStar Kennestone Regional Medical Center

    Marietta, Georgia, 30060

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • ProMedica Toledo Hospital

    Toledo, Ohio, 43606

  • Mercy Health

    Toledo, Ohio, 43608

Other trials in United States

About this study

Official title: 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.

Conditions
Ischemic Stroke
Being tested
Thermogard XP3, Recanalization only
Keywords
Therapeutic Hypothermia, Cooling, Stroke, Neurological Acute Care
Medical subject headings
Ischemic Stroke, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thermogard XP3Device

    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.

  • Recanalization onlyProcedure or surgery

    Standard of Care for recanalization

Study groups in NCT03804060
Study groupRoleWhat they receive
Cooling + RecanalizationExperimentalThe 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.
Receives: Device: Thermogard XP3
Recanalization onlyActive comparatorThe 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.
Receives: Procedure: Recanalization only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 hour after thrombectomy

  2. Mean door-to-Recanalization time

    door-to-Recanalization time

    Measured: perioperative

  3. Rate of hemorrhagic conversion in each arm within 36 hours of Recanalization

    Rate of hemorrhagic conversion

    Measured: 36 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2019
  2. Study start23 May 2019
  3. Primary completion1 May 2024
  4. Study completion1 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03804060
Sponsor's protocol ID
EDC-3599
Acronym
RECCLAIM-II
Status last verified
May 2024
First submitted
9 Jan 2019
Last updated
16 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Kass-Hout T, Horn C, Sun CJ, Yoo A, Zaidat OO, Gupta AC, Zaidi SF, Chebl AB, Lin E, Al-Bayati A, Badjatia N, Liebeskind D, Zhang Y, Wilburn P, Gupta R. Adjuvant Systemic Hypothermia During Mechanical Thrombectomy (ReCCLAIM II): A Multicenter, Randomized, Controlled Trial. Stroke. 2026 Oct 9. doi: 10.1161/STROKEAHA.126.056651. Online ahead of print.

    PubMed 42852505

Questions about this trial

What is this clinical trial studying?

A study testing Thermogard XP3 and Recanalization only in people with Ischemic Stroke, run by ZOLL Circulation, Inc., USA at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Test Arm patients achieving target temperature (time frame: 1 hour after thrombectomy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03804060, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.

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