Efficacy and Safety of Balloon Guide Catheter in Mechanical Thrombectomy Patients
ESCAPE
1 other identifier
interventional
155
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2018
Shorter than P25 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2018
CompletedStudy Start
First participant enrolled
November 25, 2018
CompletedFirst Posted
Study publicly available on registry
November 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2020
CompletedDecember 4, 2018
December 1, 2018
1 year
November 24, 2018
December 3, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Distal embolization,
After mechanical thrombectomy, usually within 3 hours
Secondary Outcomes (10)
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
- +5 more secondary outcomes
Other Outcomes (1)
Safety (occurrence of adverse events and serious adverse events)
7 days
Study Arms (2)
Balloon guide catheter group
EXPERIMENTALmechanical thrombectomy with a balloon guide catheter group
Non-balloon guide catheter group
ACTIVE COMPARATORmechanical thrombectomy with a non-balloon guide catheter group
Interventions
Use a balloon guide catheter in the mechanical thrombectomy
Use a non-balloon guide catheter in the mechanical thrombectomy
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Suzhou Municipal Hoapital
Suzhou, Anhui, China
Xuan Wu Hospital，Capital Medical University
Beijing, Beijing Municipality, 100069, China
Lu He hospital, Capital Medical University
Beijing, Beijing Municipality, 101149, China
Shengli Oilfield Central Hospital
Dongying, Shandong, China
Nanyang City Center Hospital
Nanyang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Related Publications (1)
Ma H, Che R, Zhang Q, Yu W, Wu L, Zhao W, Li M, Wu D, Wu C, Ji X. The optimum anticoagulation time after endovascular thrombectomy for atrial fibrillation-related large vessel occlusion stroke: a real-world study. J Neurol. 2023 Apr;270(4):2084-2095. doi: 10.1007/s00415-022-11515-y. Epub 2023 Jan 3.
PMID: 36596867DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 24, 2018
First Posted
November 27, 2018
Study Start
November 25, 2018
Primary Completion
November 25, 2019
Study Completion
February 28, 2020
Last Updated
December 4, 2018
Record last verified: 2018-12