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

NCT ID: NCT05391399

Last Updated: 2022-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-29
• Study Completion Date: 2021-07-19

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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

group A 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 Type: EXPERIMENTAL

Interlocking detachable coils system

Intervention Type: DEVICE

Mainly used to block or slow blood flow in the peripheral vascular system during embolization procedures.

group B 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.

Group Type: ACTIVE_COMPARATOR

Interlock Fibered IDC Occlusion System

Intervention Type: DEVICE

Mainly used to block or slow blood flow in the peripheral vascular system during embolization procedures.

Interventions

Interlocking detachable coils system

Mainly used to block or slow blood flow in the peripheral vascular system during embolization procedures.

Intervention Type: DEVICE

Interlock Fibered IDC Occlusion System

Mainly used to block or slow blood flow in the peripheral vascular system during embolization procedures.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Shenqi Medical Technology Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

CP01-025A

Identifier Type: -

Identifier Source: org_study_id