The Trial of Ewata Balloon Guiding in the Application of Thrombectomy

Not Applicable

Completed

• Conditions: Acute Ischemic Stroke
• Interventions: Device: Ewata balloon guiding

• Registration Number: NCT04315844
• Lead Sponsor: Beijing Tiantan Hospital

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.

Study Timeline

• Study Start: 2017-07-25
• Study First Submitted: 2020-03-18
• Study First Submitted QC: 2020-03-18
• Study First Posted: 2020-03-20
• Primary Completion: 2020-06-30
• Study Completion: 2020-09-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
balloon	Ewata balloon guiding	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.

Primary Outcome Measures

Name	Time	Method
technical success rate of ewata	intraoperative	When the balloon guiding catheter arrives at the desired location, the thrombectomy instrument can enter the balloon guiding catheter smoothly, which can be opened successfully when needed to form a local blockage of blood flow. After the thrombectomy, the thrombectomy instrument can be withdrawn back into the guide catheter, which is considered as a success.Ewata balloon guide catheter should be used at least once during thrombectomy

Secondary Outcome Measures

Name	Time	Method
The time from the successful puncture to the expected location of ewata	intraoperative	time data
Rate of Vascular recanalization	postoperative	TICI≥2b
Good prognosis rate at 90 days	90 days	(mRS≤2)
24-hour mortality	24-hour	The number of all deaths reported will be recorded and adjudicated
Rate of intraoperative adverse events	intraoperative	including vascular perforation , incision,vasospasm caused by balloon guiding,balloon guide catheter rupture and other instrument-related accidents
The time from successful puncture to recanalization	intraoperative	time data,TICI≥2b
90-day mortality	90-day	The number of all deaths reported will be recorded and adjudicated
The thrombus escapes from the target vessel to other vessels to form new embolism	intraoperative	The form of New thrombosis Judged by DSA or MRA
Rate of symptomatic intracranial hemorrhage within 24 hours	24 hours	CT/NIHSS

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China