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

NCT07156409 | Not Yet Recruiting

• 1 other identifier: ZTHTL202501
• Study Type: interventional
• Target: 139
• Locations: 0 countries
• Sites: N/A

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

Conditions

Peripheral Arterial Hemorrhage; Arteriovenous Malformation; Arteriovenous Fistula; Peripheral Aneurysm

Outcome Measures

Primary Outcomes (1)

• Rate of technical success (embolization of target vessel)

  Angiographic imaging confirmed successful occlusion of the target vessel segment with no blood perfusion.

  Immediately after the intervention

Secondary Outcomes (5)

• Rate of treated vessel occlusion

  6 months

• Target Vessel Re-intervention Rate

  30 days,3 months,6 months from procedure date

• All-cause mortality rate

  6 months from procedure date

• 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

Study Arms (1)

Peripheral Embolization Coil System

EXPERIMENTAL

Device: Peripheral Embolization Coil System

Interventions

Peripheral Embolization Coil System DEVICE

Primarily used to block or reduce the blood flow velocity in the peripheral vascular system

Peripheral Embolization Coil System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• The target vessel has undergone any previous embolization therapy or surgical intervention, or has recurrent disease;
• Definite allergy, resistance, or contraindication to antiplatelet drugs, anticoagulants, contrast media, and/or anesthetics;
• Females who are pregnant, breastfeeding, or planning to become pregnant within 6 months; males planning for parenthood within the next 6 months;
• Subjects currently participating in other drug or device clinical trials who have not reached the trial endpoint;
• Investigators deem the subject unsuitable for participation in this study.

Sponsors & Collaborators

• Suzhou Zenith Vascular Scitech Co., Ltd.: lead
• The First Affiliated Hospital of Soochow University: collaborator

MeSH Terms

Conditions

Arteriovenous Malformations; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Vascular Fistula; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 5, 2025
• Study Start: September 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-09