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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03754738
Recruitment Status : Unknown
Verified December 2018 by Ji Xunming,MD,PhD, Capital Medical University.
Recruitment status was:  Recruiting
First Posted : November 27, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Ji Xunming,MD,PhD, Capital Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mechanical Thrombectomy Stroke Balloon Guide Catheter Device: Balloon guide catheter Device: Non-balloon guide catheter Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Balloon Guide Catheter in Mechanical Thrombectomy Patients
Estimated Study Start Date : November 25, 2018
Estimated Primary Completion Date : November 25, 2019
Estimated Study Completion Date : February 28, 2020
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Distal embolization, [ Time Frame: After mechanical thrombectomy, usually within 3 hours ]

Secondary Outcome Measures :
  1. Modified thrombolysis in cerebral infarction 2b/3, [ Time Frame: After mechanical thrombectomy, usually within 3 hours ]
  2. Modified thrombolysis in cerebral infarction [ Time Frame: After mechanical thrombectomy, usually within 3 hours ]
  3. Modified thrombolysis in cerebral infarction 2b/3 after the first pass [ Time Frame: After the first pass, , usually within 3 hours ]
  4. First pass recanalization rate [ Time Frame: After the first pass, , usually within 3 hours ]
  5. Number of passes [ Time Frame: After mechanical thrombectomy, usually within 3 hours ]
  6. Procedure time [ Time Frame: From the procedure start to the end, usually within 3 hours ]
  7. National Institutes of Health Stroke Scale [ Time Frame: 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.

  8. Symptomatic intracranial hemorrhage [ Time Frame: 24 hours ]
  9. Modified Rankin Scale [ Time Frame: 90 days ]
    Scores on the modified Rankin scale of functional disability range from 0 (no symptoms) to 6 (death).

  10. Mortality [ Time Frame: 90 days ]

Other Outcome Measures:
  1. Safety (occurrence of adverse events and serious adverse events) [ Time Frame: 7 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03754738


Locations
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China, An Hui
Suzhou Municipal Hoapital Not yet recruiting
Suzhou, An Hui, China
Contact: Zhengfei Ma, MD         
China, Beijing
Xuan Wu Hospital，Capital Medical University Recruiting
Beijing, Beijing, China, 100069
Contact: xunming ji    861013120136877    jixunming@vip.163.com   
Lu He hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 101149
Contact: Xiaokun Geng, MD    18311055270    xgeng@ccmu.edu.cn   
China, Shandong
Shengli Oilfield Central Hospital Not yet recruiting
Dongying, Shandong, China
Contact: Zongen Gao         
Principal Investigator: Zongen Gao         
China
Nanyang City Center Hospital Recruiting
Nanyang, China
Contact: Changming Wen    13838729696    wenchangming9587@163.com   
The First Affiliated Hospital of Zhengzhou University Not yet recruiting
Zhengzhou, China
Contact: Yajun Lian         
Sponsors and Collaborators
Capital Medical University
More Information
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Responsible Party: Ji Xunming,MD,PhD, Principal Investigator, Capital Medical University
ClinicalTrials.gov Identifier: NCT03754738    
Other Study ID Numbers: 2018-ESCAPE
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No