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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 After the thrombectomy, the thrombectomy instrument can be withdrawn back into the guide catheter, which is considered as a success.Ewata balloon guide catheter should be used at least once during thrombectomy | intraoperative |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Clinical and laboratory exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Beijing | Beijing Municipality | 100000 | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| 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 |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |