Trials / Completed
CompletedNCT05391399
Use of Interlocking Detachable Coils System in Embolization of Peripheral Arterial Embolization
A Prospective, Multicenter, Randomized Controlled Clinical Trial Evaluating the Safety and Efficacy of Interlocking Detachable Coils System for Embolization of Peripheral Arterial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 121 (actual)
- Sponsor
- Shanghai Shenqi Medical Technology Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and efficacy of interlocking detachable coils system in the treatment of Chinese patients with embolization of peripheral arterial in comparison with Interlock Fibered IDC Occlusion System
Detailed description
This is a prospective, multicenter, open-label, non-inferiority, randomized controlled clinical trial. The plan is to recruit patients with peripheral arterial disease requiring embolization and then perform peripheral arterial embolization based on randomization using devices in the experimental group or control group. This trail will be conducted in a number of experimental institutions in China, and a total of 116 subjects are planned to be enrolled. All subjects were treated with the interlocking detachable coils system and were evaluated during surgery and before discharge from the treatment of experimental or control devices, followed up at 1 month, 3 months, and 6 months after surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Interlocking detachable coils system | Mainly used to block or slow blood flow in the peripheral vascular system during embolization procedures. |
| DEVICE | Interlock Fibered IDC Occlusion System | Mainly used to block or slow blood flow in the peripheral vascular system during embolization procedures. |
Timeline
- Start date
- 2019-04-29
- Primary completion
- 2021-07-19
- Completion
- 2021-07-19
- First posted
- 2022-05-26
- Last updated
- 2022-05-26
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05391399. Inclusion in this directory is not an endorsement.