The Trial of Ewata Balloon Guiding in the Application of Thrombectomy

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.

Study Overview

• Status: Completed
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Device: Ewata balloon guiding

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 Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Beijing Tiantan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	intraoperative

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 25, 2017
• Primary Completion (ACTUAL): June 30, 2020
• Study Completion (ACTUAL): September 30, 2020

Study Registration Dates

• First Submitted: March 18, 2020
• First Submitted That Met QC Criteria: March 18, 2020
• First Posted (ACTUAL): March 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: AIS balloon guiding
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: LCXY-02-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No