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
This study adopts a prospective, multicenter, single-arm target value design. It plans to enroll patients with peripheral arteriovenous diseases requiring embolization, who will be treated using the Peripheral Embolization Coil System manufactured by Suzhou Zhongtian Medical Instruments Co., Ltd. Follow-up assessments will be conducted during the procedure, prior to discharge, and at 30 days, 3 months, and 6 months post-operation to evaluate the safety and effectiveness of the Peripheral Embolization Coil System
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
139
Primarily 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.
Time frame: Immediately after the intervention
Rate of treated vessel occlusion
Angiographic imaging confirmed successful occlusion of the target vessel segment with no blood perfusion.
Time frame: 6 months
Target Vessel Re-intervention Rate
The embolized segment of the target vessel requires re-intervention/surgical intervention.
Time frame: 30 days,3 months,6 months from procedure date
All-cause mortality rate
Death from any cause
Time frame: 6 months from procedure date
Rate of Device/Procedure-Related Serious Adverse Events
Time frame: Perioperative,30 days,3 months,6 months from procedure date
Adverse Event/Serious Adverse Event Rate
Time frame: 6 months from procedure date
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