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

Shenqi Medical

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Device: Interlocking detachable coils system; Device: Interlock Fibered IDC Occlusion System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05391399

CP01-025A

Details and patient eligibility

About

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

Full 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.

Enrollment: 121 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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121 participants in 2 patient groups

group A Interlocking detachable coils system

Experimental group

Description:

The coil is designed with mechanical release, which can be recovered and repositioned at any time when the release process meets certain conditions.

Treatment:

Device: Interlocking detachable coils system

group B Interlock Fibered IDC Occlusion System

Active Comparator group

Description:

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.

Treatment:

Device: Interlock Fibered IDC Occlusion System