Efficacy and Safety of Balloon Guide Catheter in Mechanical Thrombectomy Patients

Stroke Clinical Trial

— ESCAPE  

Official title:

Efficacy and Safety of Balloon Guide Catheter in Mechanical Thrombectomy Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03754738
• Other study ID #: 2018-ESCAPE
• Status: Recruiting
• Phase: Phase 2
• Start date: November 25, 2018
• Est. completion date: February 28, 2020

Study information

• Verified date: December 2018
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 155
• Est. completion date: February 28, 2020
• Est. primary completion date: November 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Balloon Guide Catheter
• Mechanical Thrombectomy
• Stroke

Intervention

Device:
• Balloon guide catheter
Use a balloon guide catheter in the mechanical thrombectomy
• Non-balloon guide catheter
Use a non-balloon guide catheter in the mechanical thrombectomy

Locations

Country	Name	City	State
China	Lu He hospital, Capital Medical University	Beijing	Beijing
China	Xuan Wu Hospital,Capital Medical University	Beijing	Beijing
China	Shengli Oilfield Central Hospital	Dongying	Shandong
China	Nanyang City Center Hospital	Nanyang
China	Suzhou Municipal Hoapital	Suzhou	An Hui
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety (occurrence of adverse events and serious adverse events)		7 days
Primary	Distal embolization,		After mechanical thrombectomy, usually within 3 hours
Secondary	Modified thrombolysis in cerebral infarction 2b/3,		After mechanical thrombectomy, usually within 3 hours
Secondary	Modified thrombolysis in cerebral infarction		After mechanical thrombectomy, usually within 3 hours
Secondary	Modified thrombolysis in cerebral infarction 2b/3 after the first pass		After the first pass, , usually within 3 hours
Secondary	First pass recanalization rate		After the first pass, , usually within 3 hours
Secondary	Number of passes		After mechanical thrombectomy, usually within 3 hours
Secondary	Procedure time		From the procedure start to the end, usually within 3 hours
Secondary	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
Secondary	Symptomatic intracranial hemorrhage		24 hours
Secondary	Modified Rankin Scale	Scores on the modified Rankin scale of functional disability range from 0 (no symptoms) to 6 (death).	90 days
Secondary	Mortality		90 days