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

Not Applicable

Not yet recruiting

• Conditions: Peripheral Arterial Hemorrhage; Arteriovenous Malformation; Arteriovenous Fistula; Peripheral Aneurysm

• Registration Number: NCT07156409
• Lead Sponsor: Suzhou Zenith Vascular Scitech Co., Ltd.

Brief 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

Study Timeline

• Study First Submitted: 2025-08-27
• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted QC: 2025-09-04
• Last Update Submitted: 2025-09-04
• Study First Posted: 2025-09-05
• Last Update Posted: 2025-09-05
• Primary Completion: 2026-05
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

1. Aged 18 to 75 years (inclusive), regardless of gender;
2. Patients diagnosed preoperatively via imaging (including but not limited to ultrasound, CTA, MRA, DSA, etc.) with peripheral arteriovenous conditions requiring embolization therapy;
3. The visually estimated normal reference diameter of the target vessel is ≥ 3mm;
4. 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

1. The target vessel requires the concurrent use of other embolic materials (e.g., Gelfoam, embolic microspheres, liquid embolic agents, etc.);
2. Known definite history of allergy to platinum, tungsten metals, and/or any component of the investigational product;
3. Subjects with pre-existing severe cardiac, hepatic, renal, respiratory diseases, or coagulation disorders who are unsuitable for anesthesia or endovascular surgical treatment;
4. High-flow arteriovenous fistulas that may cause migration of the embolic material;
5. The target aneurysm is a blister aneurysm, dissecting aneurysm, mycotic (infectious) aneurysm, ruptured aneurysm, or aneurysm caused by connective tissue diseases;
6. 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;
7. The target vessel has undergone any previous embolization therapy or surgical intervention, or has recurrent disease;
8. Definite allergy, resistance, or contraindication to antiplatelet drugs, anticoagulants, contrast media, and/or anesthetics;
9. Females who are pregnant, breastfeeding, or planning to become pregnant within 6 months; males planning for parenthood within the next 6 months;
10. Subjects currently participating in other drug or device clinical trials who have not reached the trial endpoint;
11. Investigators deem the subject unsuitable for participation in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Rate of technical success (embolization of target vessel)	Immediately after the intervention	Angiographic imaging confirmed successful occlusion of the target vessel segment with no blood perfusion.

Secondary Outcome Measures

Name	Time	Method
Rate of treated vessel occlusion	6 months	Angiographic imaging confirmed successful occlusion of the target vessel segment with no blood perfusion.
Target Vessel Re-intervention Rate	30 days,3 months,6 months from procedure date	The embolized segment of the target vessel requires re-intervention/surgical intervention.
All-cause mortality rate	6 months from procedure date	Death from any cause
Rate of Device/Procedure-Related Serious Adverse Events	Perioperative,30 days,3 months,6 months from procedure date
Adverse Event/Serious Adverse Event Rate	6 months from procedure date