Status:
COMPLETED
The Trial of Ewata Balloon Guiding in the Application of Thrombectomy
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
To evaluate the efficacy and security of Ewata combined with a stent device in the treatment of acute ischemic stroke within 8 hours To prove whether the clinical efficacy and safety of Ewata r is not...
Detailed Description
This clinical trial uses multicenter, single-arm, prospective trial design,people who met the enrollment requirements were performed with Ewata balloon guiding and stent type thrombectomy device.The c...
Eligibility Criteria
Inclusion
- Acute ischemic stroke
- within 8 hours
- Patients aged 18-80 years (including critical point)
- NIHSS score 4-30 (including critical points)
- Pre-onset mRS score \<2
- Large vessel lesions were detected by head CT, CTA, MRI, MRA, or DSA
- The patient or his legal guardian voluntarily signs and dates a written informed 8.consent approved by the ethics committee (IBC).
Exclusion
- Head CT exclusion criteria (exclusion if any of the following conditions are met)
- Cerebral hemorrhage
- Intracranial tumors, except for small meningiomas
- Large area of early cerebral infarction (low density shadow \>1/3 cerebral hemisphere)
- Clinical and laboratory exclusion criteria
- seizure
- Symptoms of nervous system loss improved rapidly
- Severe stroke (NIHSS≥31 points) or mild stroke (NIHSS≤3 points)
- CT examination of the skull was negative, but subarachnoid hemorrhage was not excluded from clinical symptoms
- A history of intracranial hemorrhage and subarachnoid hemorrhage
- A history of cranial trauma in the last 3 months
- A history of cerebral or myocardial infarction in the last 3 months
- A history of gastrointestinal or urinary tract bleeding in the last 3 weeks
- A history of major surgery in the last 2 weeks
- A history of arterial puncture in the last l weeks that was difficult to stop bleeding
- Patients with severe cardiac, hepatic or renal insufficiency (\>250 mol/L) or severe diabetes mellitus
- Physical examination revealed evidence of active bleeding or trauma, such as a fracture
- Oral anticoagulants have been taken, and INR\>1.7
- Blood glucose \<2.7 mmol/L or \>22.2 mmol/L
- Systolic blood pressure \>185 mmHg, or diastolic blood pressure \>110 mmHg Pregnancy
- There is a tendency of severe bleeding or bleeding disease, platelet count ≤80x109 /L
- Systemic infection without control or local infection of puncture point Hypersensitivity to contrast media
Key Trial Info
Start Date :
July 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2020
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT04315844
Start Date
July 25 2017
End Date
September 30 2020
Last Update
November 5 2020
Active Locations (1)
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1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100000