The Trial of Ewata Balloon Guiding in the Application of Thrombectomy

NCT04315844 | Completed DMC

• 1 other identifier: LCXY-02-01
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Keywords

AIS balloon guiding

Outcome Measures

Primary Outcomes (1)

• 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 After the thrombectomy, the thrombectomy instrument can be withdrawn back into the guide catheter, which is considered as a success.Ewata balloon guide catheter should be used at least once during thrombectomy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 Outcomes (9)

• Rate of Vascular recanalization

  postoperative

• Rate of intraoperative adverse events

  intraoperative

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

  intraoperative

• The time from successful puncture to recanalization

  intraoperative

• Rate of symptomatic intracranial hemorrhage within 24 hours

  24 hours

Study Arms (1)

balloon

EXPERIMENTAL

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

Interventions

Ewata balloon guiding 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.

balloon

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: March 20, 2020
• Study Start: July 25, 2017
• Primary Completion: June 30, 2020
• Study Completion: September 30, 2020
• Last Updated: November 5, 2020

Record last verified: 2020-11

Locations

CN (1)