Efficacy and Safety of Balloon Guide Catheter in Mechanical Thrombectomy Patients

Study Overview
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Brief Summary
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With mechanical thrombectomy now representing standard of care for treatment of acute ischemic stroke secondary to large vessel occlusion, identifying adjunctive techniques that result in improved outcomes for patients with LVO has become an issue of increasing importance. A number of retrospective studies have demonstrated that flow arrest during the clot retrieval process results in less clot fragmentation, lower rates of distal emboli, higher revascularization rates and improved rates of good neurological outcome.

Official Title
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Efficacy and Safety of Balloon Guide Catheter in Mechanical Thrombectomy Patients

Conditions
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Mechanical Thrombectomy, Stroke, Balloon Guide Catheter

Intervention / Treatment
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* Device: Balloon guide catheter
* Device: Non-balloon guide catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older A clinical diagnosis of acute stroke, with a deficit on the NIHSS of 2 points or more. Intracranial arterial occlusion of the distal intracranial carotid artery or middle (M1/M2) or anterior (A1/A2) cerebral artery, demonstrated with CTA, MRA, or DSA. Treatment can be initiated (groin puncture) within 6 hours of symptom onset. Planning to mechanical thrombectomy with a stenting retriever. Signed informed consent prior to entering study. Exclusion Criteria: Moderate stenosis, severe stenosis, or occlusion of the ipsilateral extracranial carotid artery. Previously deployed stents in the ipsilateral carotid artery. Dissections of the ipsilateral carotid artery. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0. Baseline platelet count < 50.000/µL. Baseline blood glucose of < 50mg/dL or >400mg/dl. Severe, sustained hypertension (SBP > 220 mm Hg or DBP > 110 mm Hg). Renal insufficiency with creatinine ≥ 3 mg/dl. Patients in sedation and intubated patients could not be included if baseline NIHSS is not obtained by a neurologist or emergency physician prior to sedation or intubation. Seizures at stroke onset which would preclude obtaining a baseline NIHSS. Unlikely to be available for 90 days follow-up (e.g. no fixed home address, visitor from overseas). Subject participating in a study involving an investigational drug or device that would impact this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Balloon guide catheter group<br>mechanical thrombectomy with a balloon guide catheter group | Device: Balloon guide catheter<br>* Use a balloon guide catheter in the mechanical thrombectomy<br>|
| Active Comparator: Non-balloon guide catheter group<br>mechanical thrombectomy with a non-balloon guide catheter group | Device: Non-balloon guide catheter<br>* Use a non-balloon guide catheter in the mechanical thrombectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distal embolization, |  | After mechanical thrombectomy, usually within 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified thrombolysis in cerebral infarction 2b/3, |  | After mechanical thrombectomy, usually within 3 hours | 
| Modified thrombolysis in cerebral infarction |  | After mechanical thrombectomy, usually within 3 hours | 
| Modified thrombolysis in cerebral infarction 2b/3 after the first pass |  | After the first pass, , usually within 3 hours | 
| First pass recanalization rate |  | After the first pass, , usually within 3 hours | 
| Number of passes |  | After mechanical thrombectomy, usually within 3 hours | 
| Procedure time |  | From the procedure start to the end, usually within 3 hours | 
| National Institutes of Health Stroke Scale | Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits. | 7 days or discharge | 
| Symptomatic intracranial hemorrhage |  | 24 hours | 
| Modified Rankin Scale | Scores on the modified Rankin scale of functional disability range from 0 (no symptoms) to 6 (death). | 90 days | 
| Mortality |  | 90 days |