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The Trial of Ewata Balloon Guiding in the Application of Thrombectomy

Primary Purpose

Acute Ischemic Stroke

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Ewata balloon guiding

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring AIS balloon guiding

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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

Sites / Locations

Beijing Tiantan Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

balloon

Arm Description

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.

Outcomes

Primary Outcome Measures

technical success rate of ewata

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

Rate of Vascular recanalization

TICI≥2b

Rate of intraoperative adverse events

including vascular perforation , incision,vasospasm caused by balloon guiding,balloon guide catheter rupture and other instrument-related accidents

The time from the successful puncture to the expected location of ewata

time data

The time from successful puncture to recanalization

time data,TICI≥2b

Rate of symptomatic intracranial hemorrhage within 24 hours

CT/NIHSS

24-hour mortality

The number of all deaths reported will be recorded and adjudicated

90-day mortality

The number of all deaths reported will be recorded and adjudicated

Good prognosis rate at 90 days

(mRS≤2)

The thrombus escapes from the target vessel to other vessels to form new embolism

The form of New thrombosis Judged by DSA or MRA

Full Information

NCT ID

NCT04315844

First Posted

March 18, 2020

Last Updated

November 3, 2020

Sponsor

Beijing Tiantan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04315844

Brief Title

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

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

July 25, 2017 (Actual)

Primary Completion Date

June 30, 2020 (Actual)

Study Completion Date

September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Ischemic Stroke

Keywords

AIS balloon guiding

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

122 (Actual)

8. Arms, Groups, and Interventions

Arm Title

balloon

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Ewata balloon guiding

Intervention Description

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.

Primary Outcome Measure Information:

Title

technical success rate of ewata

Description

Time Frame

intraoperative

Secondary Outcome Measure Information:

Title

Rate of Vascular recanalization

Description

TICI≥2b

Time Frame

postoperative

Title

Rate of intraoperative adverse events

Description

including vascular perforation , incision,vasospasm caused by balloon guiding,balloon guide catheter rupture and other instrument-related accidents

Time Frame

intraoperative

Title

The time from the successful puncture to the expected location of ewata

Description

time data

Time Frame

intraoperative

Title

The time from successful puncture to recanalization

Description

time data,TICI≥2b

Time Frame

intraoperative

Title

Rate of symptomatic intracranial hemorrhage within 24 hours

Description

CT/NIHSS

Time Frame

24 hours

Title

24-hour mortality

Description

The number of all deaths reported will be recorded and adjudicated

Time Frame

24-hour

Title

90-day mortality

Description

The number of all deaths reported will be recorded and adjudicated

Time Frame

90-day

Title

Good prognosis rate at 90 days

Description

(mRS≤2)

Time Frame

90 days

Title

The thrombus escapes from the target vessel to other vessels to form new embolism

Description

The form of New thrombosis Judged by DSA or MRA

Time Frame

intraoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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

Facility Information:

Facility Name

Beijing Tiantan Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100000

Country

China

12. IPD Sharing Statement

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The Trial of Ewata Balloon Guiding in the Application of Thrombectomy

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