Clinical trial NCT04315844: The Trial of Ewata Balloon Guiding in the Application of Thrombectomy
Official title: The Trial of Ewata Balloon Guiding in the Application of Thrombectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: AIS balloon guiding
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2020-03-20
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 inferior to other guidings.

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 clinical results were compared with those of other historical guiding catheter products combined with the stent type thrombectomy device to to evaluate the clinical efficacy and safety of Ewata balloon guide catheter in combination with a stent for thrombectomy.

Eligibility criteria: Inclusion Criteria:

1. Acute ischemic stroke
2. within 8 hours
3. Patients aged 18-80 years (including critical point)
4. NIHSS score 4-30 (including critical points)
5. Pre-onset mRS score \<2
6. Large vessel lesions were detected by head CT, CTA, MRI, MRA, or DSA
7. The patient or his legal guardian voluntarily signs and dates a written informed 8.consent approved by the ethics committee (IBC).

Exclusion Criteria:

1. Head CT exclusion criteria (exclusion if any of the following conditions are met)
2. Cerebral hemorrhage
3. Intracranial tumors, except for small meningiomas
4. Large area of early cerebral infarction (low density shadow \>1/3 cerebral hemisphere)

Clinical and laboratory exclusion criteria

1. seizure
2. Symptoms of nervous system loss improved rapidly
3. Severe stroke (NIHSS≥31 points) or mild stroke (NIHSS≤3 points)
4. CT examination of the skull was negative, but subarachnoid hemorrhage was not excluded from clinical symptoms
5. A history of intracranial hemorrhage and subarachnoid hemorrhage
6. A history of cranial trauma in the last 3 months
7. A history of cerebral or myocardial infarction in the last 3 months
8. A history of gastrointestinal or urinary tract bleeding in the last 3 weeks
9. A history of major surgery in the last 2 weeks
10. A history of arterial puncture in the last l weeks that was difficult to stop bleeding
11. Patients with severe cardiac, hepatic or renal insufficiency (\>250 mol/L) or severe diabetes mellitus
12. Physical examination revealed evidence of active bleeding or trauma, such as a fracture
13. Oral anticoagulants have been taken, and INR\>1.7
14. Blood glucose \<2.7 mmol/L or \>22.2 mmol/L
15. Systolic blood pressure \>185 mmHg, or diastolic blood pressure \>110 mmHg Pregnancy
16. There is a tendency of severe bleeding or bleeding disease, platelet count ≤80x109 /L
17. Systemic infection without control or local infection of puncture point Hypersensitivity to contrast media

Primary outcomes:
measure: technical success rate of ewata
timeFrame: intraoperative
Secondary outcomes:
measure: Rate of Vascular recanalization
timeFrame: postoperative
measure: Rate of intraoperative adverse events
timeFrame: intraoperative
measure: The time from the successful puncture to the expected location of ewata
timeFrame: intraoperative
measure: The time from successful puncture to recanalization
timeFrame: intraoperative
measure: Rate of symptomatic intracranial hemorrhage within 24 hours
timeFrame: 24 hours
measure: 24-hour mortality
timeFrame: 24-hour
measure: 90-day mortality
timeFrame: 90-day
measure: Good prognosis rate at 90 days
timeFrame: 90 days
measure: The thrombus escapes from the target vessel to other vessels to form new embolism
timeFrame: intraoperative
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
References: