Clinical trial NCT05391399: Use of Interlocking Detachable Coils System in Embolization of Peripheral Arterial Embolization
Official title: A Prospective, Multicenter, Randomized Controlled Clinical Trial Evaluating the Safety and Efficacy of Interlocking Detachable Coils System for Embolization of Peripheral Arterial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Peripheral Arterial Disease
Lead sponsor: Shanghai Shenqi Medical Technology Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-05-26
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: target vessel occlusion rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
state: Shanghai
Study officials:
References: