Use of Interlocking Detachable Coils System in Embolization of Peripheral Arterial Embolization

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Device: Interlocking detachable coils system; Device: Interlock Fibered IDC Occlusion System

• Registration Number: NCT05391399
• Lead Sponsor: Shanghai Shenqi Medical Technology Co., Ltd

Brief 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.

Study Timeline

• Study Start: 2019-04-29
• Primary Completion: 2021-07-19
• Study Completion: 2021-07-19
• Status Verified: 2022-05
• Study First Submitted: 2022-05-22
• Study First Submitted QC: 2022-05-22
• Last Update Submitted: 2022-05-22
• Study First Posted: 2022-05-26
• Last Update Posted: 2022-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

1. Age 18-80 years;
2. Subject diagnosed with peripheral arterial embolization by preoperative imaging (CTA);
3. The target vessel can be embolized in one operation;
4. The visual diameter of the target blood vessel is 5mm-30mm;
5. Subjects or their legal representatives can understand the purpose of the trial, voluntarily participate and sign the written informed consent, and can be followed up.

Exclusion Criteria

1. Definite allergy, resistance or contraindication to antiplatelet agents, anticoagulants, contrast agents and/or anesthetics;
2. Definite allergy to platinum, tungsten and/or any substance in the test coil;
3. Subjects are not suitable for anesthesia or endovascular surgery, such as those with severe respiratory, heart, lung, liver, kidney disease or coagulation disorders (such as hemophilia);
4. The target vessel has undergone previous surgery and/or major cardiovascular surgery within 3 months;
5. The target aneurysm is dissecting aneurysm, infected aneurysm, ruptured aneurysm, and aneurysm caused by connective tissue disease;
6. Women who are pregnant or breastfeeding;
7. Subjects who are participating in clinical trials of other drugs or devices that have not reached the end point of the trial;
8. The researcher believes that it is not suitable to participate in the trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A Interlocking detachable coils system	Interlocking detachable coils system	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	Interlock Fibered IDC Occlusion System	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.

Primary Outcome Measures

Name	Time	Method
target vessel occlusion rate	6 months	no blood flow through the occluded segment of the target vessel

Trial Locations

Locations (1)

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China