The Clinical Application of Peripheral Embolization Coil Systems in Arteriovenous Embolization Wi… (NCT07156409) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Clinical Application of Peripheral Embolization Coil Systems in Arteriovenous Embolization Within the Peripheral Vasculature
139 participantsStarted 2025-09
Plain-language summary
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
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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;
✕. The target aneurysm is a blister aneurysm, dissecting aneurysm, mycotic (infectious) aneurysm, ruptured aneurysm, or aneurysm caused by connective tissue diseases;
✕. Severe vascular stenosis or tortuosity, or anatomical anomalies where it is anticipated that the device will be difficult to navigate to the lesion site, or other uncommon anatomies that may interfere with device use;
What they're measuring
1
Rate of technical success (embolization of target vessel)