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

Peripheral Arterial Disease Clinical Trial

Official title:

A Prospective, Multicenter, Randomized Controlled Clinical Trial Evaluating the Safety and Efficacy of Interlocking Detachable Coils System for Embolization of Peripheral Arterial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05391399
• Other study ID #: CP01-025A
• Status: Completed
• Phase: N/A
• Start date: April 29, 2019
• Est. completion date: July 19, 2021

Study information

• Verified date: May 2022
• Source: Shanghai Shenqi Medical Technology Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: July 19, 2021
• Est. primary completion date: July 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Interlocking detachable coils system
Mainly used to block or slow blood flow in the peripheral vascular system during embolization procedures.
• Interlock Fibered IDC Occlusion System
Mainly used to block or slow blood flow in the peripheral vascular system during embolization procedures.

Locations

Country	Name	City	State
China	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Shenqi Medical Technology Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	target vessel occlusion rate	no blood flow through the occluded segment of the target vessel	6 months