Trials / Completed
CompletedNCT04315844
The Trial of Ewata Balloon Guiding in the Application of Thrombectomy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 122 (actual)
- Sponsor
- Beijing Tiantan Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2017-07-25
- Primary completion
- 2020-06-30
- Completion
- 2020-09-30
- First posted
- 2020-03-20
- Last updated
- 2020-11-05
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04315844. Inclusion in this directory is not an endorsement.