The Clinical Application of Peripheral Embolization Coil Systems in Arteriovenous Embolization Wi… (NCT07156409) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Clinical Application of Peripheral Embolization Coil Systems in Arteriovenous Embolization Within the Peripheral Vasculature
139 participantsStarted 2025-09
Plain-language 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
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of technical success (embolization of target vessel)
. 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;