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The Trial of Ewata Balloon Guiding in the Application of Thrombectomy

NCT ID: NCT04315844

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-25

Study Completion Date

2020-09-30

Brief Summary

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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

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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.

Conditions

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Acute Ischemic Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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balloon

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.

Group Type EXPERIMENTAL

Ewata balloon guiding

Intervention Type DEVICE

The balloon guide catheter is coaxial cavity and reinforced braided catheter with varying stiffness echelon.The distal end is marked by an impermeable ray, the proximal end has a bifurcated ruhr interface, and the end is embedded with a compliance balloon.The product label indicates the size of the balloon guide catheter and the maximum volume of the balloon.

Interventions

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Ewata balloon guiding

The balloon guide catheter is coaxial cavity and reinforced braided catheter with varying stiffness echelon.The distal end is marked by an impermeable ray, the proximal end has a bifurcated ruhr interface, and the end is embedded with a compliance balloon.The product label indicates the size of the balloon guide catheter and the maximum volume of the balloon.

Intervention Type DEVICE

Eligibility Criteria

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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

2. Cerebral hemorrhage
3. Intracranial tumors, except for small meningiomas
4. Large area of early cerebral infarction (low density shadow \>1/3 cerebral hemisphere)


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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhongrong Miao

Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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LCXY-02-01

Identifier Type: -

Identifier Source: org_study_id