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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A Interlocking detachable coils system | Experimental | The coil is designed with mechanical release, which can be recovered and repositioned at any time when the release process meets certain conditions. |
|
| group B Interlock Fibered IDC Occlusion System | Active Comparator | The coil adopts the design of mechanical release, and can be recovered, repositioned and released at any time when the release process meets certain conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interlocking detachable coils system | Device | Mainly used to block or slow blood flow in the peripheral vascular system during embolization procedures. |
|
| Measure | Description | Time Frame |
|---|---|---|
| target vessel occlusion rate | no blood flow through the occluded segment of the target vessel | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Shanghai | Shanghai Municipality | 200011 | China |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| Interlock Fibered IDC Occlusion System | Device | Mainly used to block or slow blood flow in the peripheral vascular system during embolization procedures. |
|
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |