Status:
COMPLETED
Use of Interlocking Detachable Coils System in Embolization of Peripheral Arterial Embolization
Lead Sponsor:
Shanghai Shenqi Medical Technology Co., Ltd
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
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 wit...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2021
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT05391399
Start Date
April 29 2019
End Date
July 19 2021
Last Update
May 26 2022
Active Locations (1)
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1
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 200011