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

NCT05391399 | Completed

• 1 other identifier: CP01-025A
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• target vessel occlusion rate

  no blood flow through the occluded segment of the target vessel

  6 months

Study Arms (2)

group A Interlocking detachable coils system

EXPERIMENTAL

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

group B Interlock Fibered IDC Occlusion System

ACTIVE COMPARATOR

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

Interventions

Interlocking detachable coils system DEVICE

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

group A Interlocking detachable coils system

Interlock Fibered IDC Occlusion System DEVICE

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

group B Interlock Fibered IDC Occlusion System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years;
• Subject diagnosed with peripheral arterial embolization by preoperative imaging (CTA);
• The target vessel can be embolized in one operation;
• The visual diameter of the target blood vessel is 5mm-30mm;
• 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.

You may not qualify if:

• Definite allergy, resistance or contraindication to antiplatelet agents, anticoagulants, contrast agents and/or anesthetics;
• Definite allergy to platinum, tungsten and/or any substance in the test coil;
• 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);
• The target vessel has undergone previous surgery and/or major cardiovascular surgery within 3 months;
• The target aneurysm is dissecting aneurysm, infected aneurysm, ruptured aneurysm, and aneurysm caused by connective tissue disease;
• Women who are pregnant or breastfeeding;
• Subjects who are participating in clinical trials of other drugs or devices that have not reached the end point of the trial;
• The researcher believes that it is not suitable to participate in the trial.

Sponsors & Collaborators

• Shanghai Shenqi Medical Technology Co., Ltd: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200011, China

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2022
• First Posted: May 26, 2022
• Study Start: April 29, 2019
• Primary Completion: July 19, 2021
• Study Completion: July 19, 2021
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)