Efficacy and Safety of Balloon Guide Catheter in Mechanical Thrombectomy Patients

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-25

Study Completion Date

2020-02-28

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.

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Detailed Description

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Conditions

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Mechanical Thrombectomy Stroke Balloon Guide Catheter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Balloon guide catheter group

mechanical thrombectomy with a balloon guide catheter group

Group Type EXPERIMENTAL

Balloon guide catheter

Intervention Type DEVICE

Use a balloon guide catheter in the mechanical thrombectomy

Non-balloon guide catheter group

mechanical thrombectomy with a non-balloon guide catheter group

Group Type ACTIVE_COMPARATOR

Non-balloon guide catheter

Intervention Type DEVICE

Use a non-balloon guide catheter in the mechanical thrombectomy

Interventions

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Balloon guide catheter

Use a balloon guide catheter in the mechanical thrombectomy

Intervention Type DEVICE

Non-balloon guide catheter

Use a non-balloon guide catheter in the mechanical thrombectomy

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No