Acute Ischemic Stroke
Conditions
Keywords
AIS balloon guiding
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.
Interventions
DEVICEEwata 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.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 After the thrombectomy, the thrombectomy instrument can be withdrawn back into the guide catheter, which is considered as a success.Ewata balloon guide catheter should be used at least once during thrombectomy |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
| Measure | Time frame | Description |
|---|---|---|
| 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 the successful puncture to the expected location of ewata | intraoperative | time data |
| The time from successful puncture to recanalization | intraoperative | time data,TICI≥2b |
| Rate of symptomatic intracranial hemorrhage within 24 hours | 24 hours | CT/NIHSS |
| Rate of Vascular recanalization | postoperative | TICI≥2b |
| 90-day mortality | 90-day | The number of all deaths reported will be recorded and adjudicated |
| Good prognosis rate at 90 days | 90 days | (mRS≤2) |
| 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 |
| 24-hour mortality | 24-hour | The number of all deaths reported will be recorded and adjudicated |
Countries
China
Outcome results
None listed