Remote Ischemic Conditioning Paired With Endovascular Treatment for Acute Ischemic Stroke "RICPETAIS"

Not yet recruiting

Phase 1/2 Results N/A

Eligibility Criteria

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. The ASITN/SIR collateral grading scale <2 before recanalizing and TICI>1 after recanalizing, all these scores are determined by DSA imaging;
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. Occlusion (TICI 0-1) of the intracranial middle cerebral artery M1 segment, as evidenced by angiogram;
7. Patient treatable within six hours of symptom onset;
8. Informed consent obtained from patient or acceptable patient's surrogate

Exclusion Criteria

Clinical 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;
Neuroimaging criteria:
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.