Remote Ischemic Conditioning Paired With Endovascular Treatment for Acute Ischemic Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2023-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Ischemic stroke, which is due to the occlusion of a cerebral blood vessel, comprises nearly 80-90% of all strokes. Currently, reperfusion of the salvageable tissue via thrombolytic drug or endovascular treatment is the most effective strategy to reduce brain damage. However, after recanalizing the occluded vessels, subsequent reperfusion injury is inevitable. It may not only weaken the therapeutic effects of timely reperfusion but also impede patients' recovery. Moreover, thousands of neuroprotective drugs effective in experimental models have been proved to be unsuccessful in clinical trials. Therefore, effective strategies are urgently needed to prevent and treat cerebral reperfusion injury and further improve the prognosis of acute ischemic stroke.

Researchers applied remote ischemic conditioning to mouse model of focal cerebral reperfusion injury and found that it could reduce cerebral infarct size. And clinical researches demonstrated that remote ischemic conditioning was an effective strategy to improve cerebral perfusion and prevent recurrent stroke in patients with ischemic stroke. However, whether remote ischemic conditioning is safe and effective in protecting patients with large-vessel ischemic stroke and undergoing endovascular treatment is still unclear. The investigators' hypothesis is that RIC is a safe and effective strategy to reduce brain injuries in stroke patients undergoing endovascular treatment.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Remote Ischemic Conditioning Paired With Endovascular Treatment for Acute Ischemic Stroke (REVISE-1)

NCT03210051

Acute Stroke

COMPLETED PHASE1

Prevention of Ischemic Conditions in Non-disabling Stroke/Transient Ischemic Attack With Remote Ischemic Conditioning

NCT03004820

Transient Ischemic Attack Non-disabling Stroke

COMPLETED NA

Safety and Effectiveness of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis in Treating Acute Ischemic Stroke

NCT04027621

Acute Ischemic Stroke

COMPLETED NA

Safety and Efficacy Study of Remote Ischemic Conditioning Combined With Endovascular Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion of Anterior Circulation

NCT04977869

Acute Ischemic Stroke

COMPLETED NA

Protective Effects of Remote Limb Ischemic Preconditioning on Acute Cerebral Infarction

NCT01672515

Stroke

UNKNOWN PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

RIC group

RIC (remote ischemic conditioning) paired with endovascular treatment.

Group Type EXPERIMENTAL

Remote ischemic conditioning.

Intervention Type DEVICE

The RIC procedure consists of four cycles of unilateral arm ischemia for 5 minutes, which was followed by reperfusion for another 5 minutes. The procedure is performed with an electric, autocontrol device with a cuff that inflated to a pressure of 200 mmHg during the ischemia period. RIC is performed before recanalization of the occluded artery, immediately following successful recanalization, and once daily for the subsequent 7 days.

Endovascular treatment.

Intervention Type PROCEDURE

Endovascular treatment of acute ischemic stroke is performed by experienced neuroradiologist according to the latest guideline from American Heart Association and American Stroke Association.It includes thrombectomy, intra-arterial thrombolysis, thrombus aspiration, stenting and balloon angioplasty.

Sham group

Sham RIC (remote ischemic conditioning) paired with endovascular treatment.

Group Type SHAM_COMPARATOR

Endovascular treatment.

Intervention Type PROCEDURE

Endovascular treatment of acute ischemic stroke is performed by experienced neuroradiologist according to the latest guideline from American Heart Association and American Stroke Association.It includes thrombectomy, intra-arterial thrombolysis, thrombus aspiration, stenting and balloon angioplasty.

Sham remote ischemic conditioning

Intervention Type DEVICE

The sham RIC procedure consists of four cycles of unilateral arm ischemia for 5 minutes, which was followed by reperfusion for another 5 minutes. The procedure is performed with an electric, autocontrol device with a cuff that inflated to a pressure of 30 mmHg during the ischemia period. Sham RIC is performed before recanalization of the occluded artery, immediately following successful recanalization, and once daily for the subsequent 7 days.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Remote ischemic conditioning.

The RIC procedure consists of four cycles of unilateral arm ischemia for 5 minutes, which was followed by reperfusion for another 5 minutes. The procedure is performed with an electric, autocontrol device with a cuff that inflated to a pressure of 200 mmHg during the ischemia period. RIC is performed before recanalization of the occluded artery, immediately following successful recanalization, and once daily for the subsequent 7 days.

Intervention Type DEVICE

Endovascular treatment.

Endovascular treatment of acute ischemic stroke is performed by experienced neuroradiologist according to the latest guideline from American Heart Association and American Stroke Association.It includes thrombectomy, intra-arterial thrombolysis, thrombus aspiration, stenting and balloon angioplasty.

Intervention Type PROCEDURE

Sham remote ischemic conditioning

The sham RIC procedure consists of four cycles of unilateral arm ischemia for 5 minutes, which was followed by reperfusion for another 5 minutes. The procedure is performed with an electric, autocontrol device with a cuff that inflated to a pressure of 30 mmHg during the ischemia period. Sham RIC is performed before recanalization of the occluded artery, immediately following successful recanalization, and once daily for the subsequent 7 days.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

RIC Sham RIC

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Acute ischemic stroke where patient is ineligible for intravenous thrombolytic treatment or the treatment is contraindicated, or where patient has received intravenous thrombolytic therapy without recanalization;
2. Suspected proximal anterior circulation occlusion;
3. No remarkable pre-stroke functional disability (mRS ≤ 1);
4. Baseline NIHSS score obtained prior to randomization must be ≥6;
5. Age ≥18 and ≤ 80;
6. Patient treatable within 24 hours of symptom onset;
7. Informed consent obtained from patient or acceptable patient's surrogate

Exclusion Criteria

1. Identified hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \> 3.0;
2. Baseline platelet count \< 30\*109/L;
3. Baseline blood glucose of \< 2.7mmol/L or \>22.2mmol/L;
4. Renal insufficiency with creatinine ≥ 265 umol/L;
5. Severe, sustained hypertension (SBP \> 185 mmHg or DBP \> 110 mmHg);
6. Rapidly improving symptoms at the discretion of the investigator;
7. Seizures at stroke onset which would preclude obtaining a baseline NIHSS;
8. Serious, advanced, or terminal illness with anticipated life expectancy of less than one year;
9. History of life threatening allergy to contrast medium, Nickel, Titanium metals or their alloys;
10. Woman of childbearing potential who is known to be pregnant or lactating or who has a positive pregnancy test on admission;
11. Subject participating in a study involving other drug or device trial study;
12. Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations;
13. Unlikely to be available for 90-day follow-up;
14. Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs;
15. Hypodensity on CT or restricted diffusion amounting to an ASPECTS score of \<7 on noncontrast CT or \<6 on DWI MRI;
16. CT or MRI evidence of hemorrhage;
17. Significant mass effect with midline shift on CT or MRI scans;
18. Angiogram shows arterial tortuosity, pre-existing stent, and/or other arterial disease, which would prevent the device from reaching the target vessel and/or preclude safe recovery of the device;
19. Subjects with artery occlusions in multiple vascular territories;
20. Evidence of intracranial tumor.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No