Efficacy and Safety of Balloon Guide Catheter in Mechanical Thrombectomy Patients (ESCAPE)

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.

Study Overview

• Status: Unknown
• Conditions: Stroke; Mechanical Thrombectomy; Balloon Guide Catheter
• Intervention / Treatment: Device: Balloon guide catheter; Device: Non-balloon guide catheter

• Study Type: Interventional
• Enrollment (Anticipated): 155
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Nanyang, China
    • Recruiting
    • Nanyang City Center Hospital
    • Contact: Changming Wen; Phone Number: 13838729696; Email: wenchangming9587@163.com
  • Zhengzhou, China
    • Not yet recruiting
    • The First Affiliated Hospital of Zhengzhou University
  • An Hui
    • Suzhou, An Hui, China
      • Not yet recruiting
      • Suzhou Municipal Hoapital
  • Beijing
    • Beijing, Beijing, China, 100069
      • Recruiting
      • Xuan Wu Hospital，Capital Medical University
      • Contact: xunming ji; Phone Number: 861013120136877; Email: jixunming@vip.163.com
    • Beijing, Beijing, China, 101149
      • Recruiting
      • Lu He hospital, Capital Medical University
      • Contact: Xiaokun Geng, MD; Phone Number: 18311055270; Email: xgeng@ccmu.edu.cn
  • Shandong
    • Dongying, Shandong, China
      • Not yet recruiting
      • Shengli Oilfield Central Hospital
      • Contact: Zongen Gao
      • Principal Investigator: Zongen Gao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality		90 days
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
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
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

Other Outcome Measures

Outcome Measure	Time Frame
Safety (occurrence of adverse events and serious adverse events)	7 days

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 25, 2018
• Primary Completion (Anticipated): November 25, 2019
• Study Completion (Anticipated): February 28, 2020

Study Registration Dates

• First Submitted: November 24, 2018
• First Submitted That Met QC Criteria: November 24, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Actual): December 4, 2018
• Last Update Submitted That Met QC Criteria: December 3, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 2018-ESCAPE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No