Clinical trial NCT03754738: Efficacy and Safety of Balloon Guide Catheter in Mechanical Thrombectomy Patients
Official title: Efficacy and Safety of Balloon Guide Catheter in Mechanical Thrombectomy Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Mechanical Thrombectomy
Stroke
Balloon Guide Catheter
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Distal embolization,
timeFrame: After mechanical thrombectomy, usually within 3 hours
Secondary outcomes:
measure: Modified thrombolysis in cerebral infarction 2b/3,
timeFrame: After mechanical thrombectomy, usually within 3 hours
measure: Modified thrombolysis in cerebral infarction
timeFrame: After mechanical thrombectomy, usually within 3 hours
measure: Modified thrombolysis in cerebral infarction 2b/3 after the first pass
timeFrame: After the first pass, , usually within 3 hours
measure: First pass recanalization rate
timeFrame: After the first pass, , usually within 3 hours
measure: Number of passes
timeFrame: After mechanical thrombectomy, usually within 3 hours
measure: Procedure time
timeFrame: From the procedure start to the end, usually within 3 hours
measure: National Institutes of Health Stroke Scale
timeFrame: 7 days or discharge
measure: Symptomatic intracranial hemorrhage
timeFrame: 24 hours
measure: Modified Rankin Scale
timeFrame: 90 days
measure: Mortality
timeFrame: 90 days
Other outcomes:
measure: Safety (occurrence of adverse events and serious adverse events)
timeFrame: 7 days
Locations:
city: Suzhou
country: China
facility: Suzhou Municipal Hoapital
state: An Hui
city: Beijing
country: China
facility: Xuan Wu Hospital，Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Lu He hospital, Capital Medical University
state: Beijing
city: Dongying
country: China
facility: Shengli Oilfield Central Hospital
state: Shandong
city: Nanyang
country: China
facility: Nanyang City Center Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
Study officials:
References: