Status:
NOT_YET_RECRUITING
The Clinical Application of Peripheral Embolization Coil Systems in Arteriovenous Embolization Within the Peripheral Vasculature
Lead Sponsor:
Suzhou Zenith Vascular Scitech Co., Ltd.
Collaborating Sponsors:
The First Affiliated Hospital of Soochow University
Conditions:
Peripheral Arterial Hemorrhage
Arteriovenous Malformation
Eligibility:
All Genders
18-75 years
Phase:
NA
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 ...
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 P...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT07156409
Start Date
September 1 2025
End Date
December 1 2026
Last Update
September 5 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.