NCT07156409尚未招募不适用
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
Suzhou Zenith Vascular Scitech Co., Ltd.0 个研究点目标入组 139 人开始时间: 2025年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 139
- 主要终点
- Rate of technical success (embolization of target vessel)
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Rate of technical success (embolization of target vessel)
时间窗: Immediately after the intervention
Angiographic imaging confirmed successful occlusion of the target vessel segment with no blood perfusion.
次要结局
- 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)
研究者
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