Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface (VSX) Global Registry

W.L.Gore & Associates27 个研究点分布在 9 个国家目标入组 614 人开始时间: 2021年10月9日最近更新: 2026年8月20日

适应症

干预措施

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 614
试验地点: 27
主要终点: Freedom from Device-Related Serious Adverse Events (SAE)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)

详细描述

This is an Observational, prospective, single-arm, multicenter, post-market registry to collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) for one of the following indications: Iliac, Superficial Femoral Artery (SFA), Superficial Femoral Artery In-stent restenosis (SFA ISR), Hemodialysis access (AV access), Visceral artery aneurysms (VAA), Trauma/Injury, Popliteal Artery Aneurysms (PAA), or Other. Approximately 35 sites in Europe will participate and a minimum of 614 patients will be enrolled in this registry. All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) will be included and followed through one year for Trauma/Injury and other; three years for VAA; five years for Iliac, SFA, SFA ISR and AV access and ten years for PAA per institutional standard of care.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age ≥ 18 years
•Signed informed consent form
•Suitable for endovascular treatment with VSX based on treating physician's best medical judgment
•Willingness of the patient to adhere to institutional standard of care follow-up requirements

排除标准

•Non-compliant lesions where full expansion of an angioplasty balloon catheter is not achievable during pre-dilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system.
•Use of the VSX Device in lesions involving a major side branch that may be covered by the endoprosthesis.
•Lesion(s) cannot be treated with available VSX Device sizes per current Instructions for Use (IFU).
•Lesion requires treatment with an altered endoprosthesis or delivery system. (Do not cut the endoprosthesis. The endoprosthesis should only be placed and deployed using the supplied catheter system).
•Previous or concurrent enrollment into this registry (e.g., previous enrollment into another treatment cohort or patient requires enrollment into more than one cohort) (Note: Only the first VSX treatment will be enrolled if concurrent VSX procedures are performed that would require enrollment into more than one cohort).
•Participation in concurrent research study or registry which may confound registry results, unless approved by Gore.
•Known hypersensitivity to heparin or a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.
•Unable to tolerate antiplatelet therapy.
•Patient has a non-controllable allergy to contrast or the VSX Device components.
•Pregnant or breast-feeding female at time of informed consent signature.
•Life expectancy < 12 months due to comorbidities.
•Patient has other medical conditions which, as determined by the investigator, may confound the data interpretation (e.g., sepsis, thrombophilic diseases, connective tissue disorders).

研究组 & 干预措施

Trauma/Injury

Subjects with traumatic or iatrogenic vessel injuries in arteries that are located in the chest cavity, abdominal cavity, or pelvis (except for aorta, coronary, innominate, carotid, vertebral, and pulmonary arteries) treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)