Remote Ischemic Conditioning Paired With Endovascular Treatment for Acute Ischemic Stroke (REVISE-1)
Acute Stroke
About this trial
This is an interventional device feasibility trial for Acute Stroke focused on measuring Acute ischemic stroke, Endovascular treatment, Remote ischemic conditioning, Reperfusion therapy, Neuroprotection
Eligibility Criteria
Inclusion Criteria:
- 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;
- No remarkable pre-stroke functional disability (mRS ≤ 1);
- Age ≥18 and ≤ 80;
- Patient treatable within six hours of symptom onset;
- Informed consent obtained from patient or acceptable patient's surrogate
Exclusion Criteria:
- Identified hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0;
- Baseline platelet count < 30*109/L;
- Baseline blood glucose of < 2.7mmol/L or >22.2mmol/L;
- Renal insufficiency with creatinine ≥ 265 umol/L;
- Severe, sustained hypertension (SBP > 185 mmHg or DBP > 110 mmHg);
- Woman of childbearing potential who is known to be pregnant or lactating;
- Subject participating in a study involving other drug or device trial study;
- Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations;
- Unlikely to be available for 90-day follow-up;
- Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs;
- Hypodensity on CT or restricted diffusion amounting to an ASPECTS score of <7 on noncontrast CT;
- CT or MRI evidence of hemorrhage;
- Significant mass effect with midline shift on CT or MRI scans;
- Subjects with artery occlusions in multiple vascular territories;
- Evidence of intracranial tumor.
Sites / Locations
- Xuanwu Hospital, Capital Medical University
Arms of the Study
Arm 1
Experimental
RIC & ET
Remote ischemic conditioning paired with endovascular treatment. RIC is a physical strategy performed by an electric autocontrol device with cuffs placed on bilateral arms and inflated to 200 mmHg for 5-min followed by deflation for 5-min, the procedures is performed repeatedly for 5 times. 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.