Remote Ischemic Conditioning Paired With Endovascular Treatment for Acute Ischemic Stroke (REVISE-2)

This is an interventional treatment trial for Acute Stroke focused on measuring Acute ischemic stroke, Endovascular treatment, Remote ischemic conditioning Read More

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.