FLOWGRAFT - A Post-Market Clinical Follow-up Study in Patients Treated With Vascular Grafts
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- JOTEC GmbH
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
The FLOWGRAFT post-market clinical follow-up study is undertaken to show the safety and performance of FlowWeave Bioseal, FlowNit Bioseal, FlowLine Bipore and FlowLine Bipore Heparin (combined named as Vascular Grafts) in the treatment of arterial diseases, such as dissection, aneurysm, intramural hematoma (IMH), penetrating aortic ulcer (PAU), contained rupture, stenosis in the aorta or peripheral arteries (lower limbs). This includes the use of FlowWeave Bioseal or FlowNit Bioseal for debranching of the head vessels in an alone standing procedure. Furthermore, it includes the use of the FlowLine Bipore and FlowLine Bipore Heparin Grafts as arterious-venous (AV) shunt.
详细描述
In this study, patients who receive a Vascular Graft for the treatment of arterial diseases (aneurysm, PAU, IMH, dissection, stenosis) of the aorta or peripheral arteries (lower limbs) or as an AV shunt will be observed. This includes patients in whom the Vascular Grafts are used for debranching or reconstruction of the head vessels. Participating physicians will be asked to provide the observations, that were collected during routine care. Written informed consent, specifically allowing the use of clinical records for this observational study, will be obtained from every patient prior to data collection.
The period of data collection will be approximately 60 + 6 months (depending on the date of the last follow-up visit) from the date of intervention for each patient.
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
- •Patient ≥ 18 years at time of written informed consent
- •Patient was selected for treatment with a commercially available Vascular Graft of JOTEC
- •Patient satisfies at least one of the following categories:
- •Acute (14 days) / subacute (15 - 90 days) dissection with double lumina in the aorta or peripheral artery / arteries (lower limb)
- •Chronic (>90 days) dissection with double lumina in the aorta or peripheral artery / arteries (lower limb)
- •Aneurysm in the aorta or peripheral artery / arteries (lower limb)
- •IMH in the aorta or peripheral artery / arteries (lower limb)
- •PAU in the aorta or peripheral artery / arteries (lower limb)
- •Contained rupture in the aorta or peripheral artery / arteries (lower limb)
- •Stenosis in the aorta or peripheral artery / arteries (lower limb)
- •Debranching of head vessels
- •Patient is willing and able to comply with all clinical study procedures and study visits.
- •Patient has given written informed consent to participate in the study.
排除标准
- •Patient has any other medical, social, or psychological problem that in the opinion of the investigator preclude them from receiving this treatment, procedures, and evaluations pre- and post-procedure.
- •Patient is scheduled for reconstruction of the tibial artery
结局指标
主要结局
Mortality
时间窗: 30-day
Rate of in-hospital all-cause mortality
次要结局
- Vascular Graft stenosis > 50% or occlusion(6-month,12-month, 24-month, 36-month, 60-month)
- Vascular Graft secondary patency (after reintervention)(6-month,12-month, 24-month, 36-month, 60-month)
- Freedom from Vascular Graft -related hemorrhage(6-month,12-month, 24-month, 36-month, 60-month)
- Vascular Graft primary patency(6-month,12-month, 24-month, 36-month, 60-month)
- New stroke(6-month,12-month, 24-month, 36-month, 60-month)
- Vascular Graft-related adverse event(30-day, 6-month,12-month, 24-month, 36-month, 60-month)
- Vascular Graft infection(6-month,12-month, 24-month, 36-month, 60-month)
- All-cause mortality(30-day, 6-month,12-month, 24-month, 36-month, 60-month)
- Pseudoaneurysm at the sutures or in the Vascular Graft(6-month,12-month, 24-month, 36-month, 60-month)
- New sepsis(6-month,12-month, 24-month, 36-month, 60-month)