Status:
UNKNOWN
Efficacy and Safety of Balloon Guide Catheter in Mechanical Thrombectomy Patients
Lead Sponsor:
Capital Medical University
Conditions:
Mechanical Thrombectomy
Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 out...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2020
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT03754738
Start Date
November 25 2018
End Date
February 28 2020
Last Update
December 4 2018
Active Locations (6)
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1
Suzhou Municipal Hoapital
Suzhou, Anhui, China
2
Xuan Wu Hospital，Capital Medical University
Beijing, Beijing Municipality, China, 100069
3
Lu He hospital, Capital Medical University
Beijing, Beijing Municipality, China, 101149
4
Shengli Oilfield Central Hospital
Dongying, Shandong, China