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.
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
- Type of treatment
- Medical device, Surgery or procedure
- 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.
- 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.
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.
- 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.
Exclusion Criteria All Exclusion Criteria must be answered NO to be eligible.
- 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
- The patient has a height of < 1.5 meters (4 feet 11 inches);
- Use of warfarin with INR > 1.7;
- Blood clinical chemistry potassium (K+) < 2.7;
- History of severe dementia and currently taking medication for cognitive impairment or behavior disorder;
- End stage renal disease on hemodialysis;
- Known presence of an IVC filter;
- Contrast dye allergy with history of anaphylaxis, known serious sensitivity to contrast agents or any condition in which angiography is contraindicated;
- Known to have contraindications to radiological imaging;
- Known allergy to meperidine or buspar or dexmedetomidine;
- Sustained hypertension (SBP > 185 or DBP > 110 unable to be treated with a continuous infusion, e.g., nicardipine);
- Baseline CT/MR showing evidence of arterial vasculitis or dissection;
- Baseline CT/MR evidence of multiple vascular territory acute stroke;
- Excessive tortuosity of cervical vessels;
- Intracranial stent in area that may impact Recanalization;
- Presence of Pulmonary embolism, ilio-femoral or deep vein thrombosis
- Presence of clinical signs of sepsis
- 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
- 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
- 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;
- 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.
- Patient has active or symptomatic COVID-19
- 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
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Recanalization only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Mean door-to-Recanalization time
door-to-Recanalization time
Measured: perioperative
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.
- First posted15 Jan 2019
- Study start23 May 2019
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- ZOLL Circulation, Inc., USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rishi Gupta, MD, MBA, Principal investigator, Wellstar Medical Group
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
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03804060
- Acronym / sponsor ID
- RECCLAIM-II / EDC-3599
- Conditions
- Ischemic Stroke
- Keywords
- Therapeutic Hypothermia, Cooling, Stroke, Neurological Acute Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- ZOLL Circulation, Inc., USAIndustry (pharma, biotech, devices)
- Study start
- 23 May 2019 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 15 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cooling + Recanalization | Experimental | Device: Thermogard XP3The 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 | Procedure: Recanalization onlyThe 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermogard XP3Cooling 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. | Device | Cooling + Recanalization |
| Recanalization onlyStandard of Care for recanalization | Procedure or surgery | Recanalization only |
Primary outcome
Percentage of Test Arm patients achieving target temperature
Time frame: 1 hour after thrombectomy
Percentage of Test Arm patients achieving target temperature < 34 ºC within 1 hour of arterial puncture for thrombectomy
Mean door-to-Recanalization time
Time frame: perioperative
door-to-Recanalization time
Rate of hemorrhagic conversion in each arm within 36 hours of Recanalization
Time frame: 36 hours
Rate of hemorrhagic conversion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Derived from this study: PubMed 42852505Kass-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rishi Gupta, MD, MBA principal investigator
Wellstar Medical Group
8 sites in 1 country: see every site and its status.
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.