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

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

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

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Interlocking detachable coils system; Device: 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 Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: Interlocking detachable coils system; Mainly used to block or slow blood flow in the peripheral vascular system during embolization procedures.
ACTIVE_COMPARATOR: 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.	Device: Interlock Fibered IDC Occlusion System; Mainly used to block or slow blood flow in the peripheral vascular system during embolization procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
target vessel occlusion rate	no blood flow through the occluded segment of the target vessel	6 months

Collaborators and Investigators

• Sponsor: Shanghai Shenqi Medical Technology Co., Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 29, 2019
• Primary Completion (ACTUAL): July 19, 2021
• Study Completion (ACTUAL): July 19, 2021

Study Registration Dates

• First Submitted: May 22, 2022
• First Submitted That Met QC Criteria: May 22, 2022
• First Posted (ACTUAL): May 26, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 22, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Peripheral Arterial Disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: CP01-025A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No