Efficacy and Safety of Balloon Guide Catheter in Mechanical Thrombectomy Patients

Phase 2

• Conditions: Balloon Guide Catheter; Mechanical Thrombectomy; Stroke
• Interventions: Device: Non-balloon guide catheter; Device: Balloon guide catheter

• Registration Number: NCT03754738
• Lead Sponsor: Capital Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-24
• Study First Submitted QC: 2018-11-24
• Study Start: 2018-11-25
• Study First Posted: 2018-11-27
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-03
• Last Update Posted: 2018-12-04
• Primary Completion: 2019-11-25
• Study Completion: 2020-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 155

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-balloon guide catheter group	Non-balloon guide catheter	mechanical thrombectomy with a non-balloon guide catheter group
Balloon guide catheter group	Balloon guide catheter	mechanical thrombectomy with a balloon guide catheter group

Primary Outcome Measures

Name	Time	Method
Distal embolization,	After mechanical thrombectomy, usually within 3 hours

Secondary Outcome Measures

Name	Time	Method
National Institutes of Health Stroke Scale	7 days or discharge	Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits.
Modified Rankin Scale	90 days	Scores on the modified Rankin scale of functional disability range from 0 (no symptoms) to 6 (death).
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
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
Procedure time	From the procedure start to the end, usually within 3 hours
Symptomatic intracranial hemorrhage	24 hours
Mortality	90 days

Trial Locations

Locations (6)

Lu He hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Nanyang City Center Hospital; 🇨🇳 Nanyang, China

Suzhou Municipal Hoapital; 🇨🇳 Suzhou, An Hui, China

Shengli Oilfield Central Hospital; 🇨🇳 Dongying, Shandong, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, China

Xuan Wu Hospital，Capital Medical University; 🇨🇳 Beijing, Beijing, China