NCT07156409

The Clinical Application of Peripheral Embolization Coil Systems in Arteriovenous Embolization Within the Peripheral Vasculature

A Prospective, Multicenter, Single-Arm Target Value Study Evaluating the Safety and Effectiveness of a Peripheral Embolization Coil System for the Treatment of Arteriovenous Embolization in the Peripheral Vasculature in a Real-World Setting

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 139 (estimated)
• Sponsor: Suzhou Zenith Vascular Scitech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

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

Conditions

• Peripheral Arterial Hemorrhage
• Arteriovenous Malformation
• Arteriovenous Fistula
• Peripheral Aneurysm

Interventions

Type	Name	Description
DEVICE	Peripheral Embolization Coil System	Primarily used to block or reduce the blood flow velocity in the peripheral vascular system

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-05-01
• Completion: 2026-12-01
• First posted: 2025-09-05
• Last updated: 2025-09-05