Evaluation of the Safety and Effectiveness of the Peripheral Embolization Coil System Manufactured by Suzhou Zhongtian Medical Instruments Co., Ltd. for the Treatment of Arteriovenous Embolization in the Peripheral Vasculature in a Real-World Setting
Aged 18 to 75 years (inclusive), regardless of gender;
Patients diagnosed preoperatively via imaging (including but not limited to ultrasound, CTA, MRA, DSA, etc.) with peripheral arteriovenous conditions requiring embolization therapy;
The visually estimated normal reference diameter of the target vessel is ≥ 3mm;
Patients or their legally authorized representatives are capable of understanding the study objectives, voluntarily participating in this study, providing signed informed consent, and able to comply with follow-up.
The target vessel requires the concurrent use of other embolic materials (e.g., Gelfoam, embolic microspheres, liquid embolic agents, etc.);
Known definite history of allergy to platinum, tungsten metals, and/or any component of the investigational product;
Subjects with pre-existing severe cardiac, hepatic, renal, respiratory diseases, or coagulation disorders who are unsuitable for anesthesia or endovascular surgical treatment;
High-flow arteriovenous fistulas that may cause migration of the embolic material;
Single group
Peripheral Embolization Coil System
DevicePrimarily used to block or reduce the blood flow velocity in the peripheral vascular system
Rate of technical success (embolization of target vessel)
Angiographic imaging confirmed successful occlusion of the target vessel segment with no blood perfusion.
Rate of treated vessel occlusion
Angiographic imaging confirmed successful occlusion of the target vessel segment with no blood perfusion.
Target Vessel Re-intervention Rate
The embolized segment of the target vessel requires re-intervention/surgical intervention.
All-cause mortality rate
Death from any cause
Rate of Device/Procedure-Related Serious Adverse Events
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Suzhou Zenith Vascular Scitech Co., Ltd.
Lead sponsor
The First Affiliated Hospital of Soochow University
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
