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

Официальное название

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

Обзор

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

Подробное описание

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

Вмешательства

• Устройство Peripheral Embolization Coil System
  Primarily used to block or reduce the blood flow velocity in the peripheral vascular system

Первичные конечные точки

• Rate of technical success (embolization of target vessel) [Срок оценки: Immediately after the intervention]

Вторичные конечные точки (5)

• Rate of treated vessel occlusion [Срок оценки: 6 months]
• Target Vessel Re-intervention Rate [Срок оценки: 30 days,3 months,6 months from procedure date]
• All-cause mortality rate [Срок оценки: 6 months from procedure date]
• Rate of Device/Procedure-Related Serious Adverse Events [Срок оценки: Perioperative,30 days,3 months,6 months from procedure date]
• Adverse Event/Serious Adverse Event Rate [Срок оценки: 6 months from procedure date]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07156409 · ZTHTL202501

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗