ESCAPE: Efficacy and Safety of Balloon Guide Catheter in Mechanical Thrombectomy Patients
Study Details
Study Description
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 |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| 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
Primary Outcome Measures
- Distal embolization, [After mechanical thrombectomy, usually within 3 hours]
Secondary Outcome Measures
- 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]
- 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.
- Symptomatic intracranial hemorrhage [24 hours]
- Modified Rankin Scale [90 days]
Scores on the modified Rankin scale of functional disability range from 0 (no symptoms) to 6 (death).
- Mortality [90 days]
Other Outcome Measures
- Safety (occurrence of adverse events and serious adverse events) [7 days]
Eligibility Criteria
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.
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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.
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Dissections of the ipsilateral carotid artery.
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Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0.
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Baseline platelet count < 50.000/µL.
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Baseline blood glucose of < 50mg/dL or >400mg/dl.
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Severe, sustained hypertension (SBP > 220 mm Hg or DBP > 110 mm Hg).
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Renal insufficiency with creatinine ≥ 3 mg/dl.
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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.
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Suzhou Municipal Hoapital | Suzhou | An Hui | China | |
| 2 | Xuan Wu Hospital，Capital Medical University | Beijing | Beijing | China | 100069 |
| 3 | Lu He hospital, Capital Medical University | Beijing | Beijing | China | 101149 |
| 4 | Shengli Oilfield Central Hospital | Dongying | Shandong | China | |
| 5 | Nanyang City Center Hospital | Nanyang | China | ||
| 6 | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | China |
Sponsors and Collaborators
- Capital Medical University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2018-ESCAPE