"Arterial-Venous Reversal Flow in "No-option" Chronic Limb-threating Ischemia (CLTI) Patients"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 9
- 主要终点
- Safety Composite
研究概览
简要总结
The objective of the study is to evaluate early safety and effectiveness of the percutaneous deep foot venous arterialization performed in clinical practice, in an unselected population of patients with "no-option" CLTI.
详细描述
Critical lower Limb Threatening Ischemia is the most advanced stage of lower limb arterial disease and is associated with a high risk of mortality and major amputation.Literature data indicate that about 5-10% of patients with peripheral arterial disease have a risk of developing CLTI, therefore the most advanced stage of arterial disease of the lower limbs, within 5 years and have a mortality of 20% at 6 months after diagnosis of CLTI.Despite the continuous improvement of the techniques and materials used in the revascularization of these patients, the data of the Literature show that in about 10-15% of these patients revascularization is impossible or ineffective. This condition is defined as: "no-option" CLTI.Therefore, for patients with "no-option" CLTI an alternative treatment for limb rescue may be considered the use of arterialization of the venous plexus of the foot; that is, to use to bring the arterial flow to the foot a healthy conduit, such as the vein, instead of the diseased artery and no longer usable.
The present study is designed as a multicentre, prospective, single-arm, observational study.
All eligible subjects for undergoing PiPER procedure at sites participating in the study will be considered for enrolment and will be asked to give consent prior to participating.
Subjects will be considered enrolled in the study at the time written informed consent is given to the use of their personal data. Once patients are enrolled, their demographics, medical history, disease-relevant conditions, treatment details and outcomes will be collected for up to 24 months from the procedure.
The study will collect information about the medical care patients receive during their planned procedure. No additional testing or procedures will be done.
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
- •Patient has signed an approved informed consent form
- •All patients, with non-revascularizable critical lower limb ischemia defined on the basis of 2 previous unsuccessful Percutaneous Transluminal Angioplasty (PTA) attempts or on severe Medial Artery Calcification (MAC)/Small Artery Disease (SAD) stage.
- •Patient with Critical Limb Ischaemia, Rutherford category, 5 (minor tissue loss) or 6 (major tissue loss) with active trophic lesions
- •Ejection Fraction > 30%
排除标准
- •Subject no able to perform the follow up or other factors making clinical follow-up difficult
- •Patients with critical ischaemia of the lower limbs revascularizable by bypass or angioplasty, critical ischaemia characterised by rest pain (Rutherford class ≤ 4)
- •Ejection Fraction < 30%
结局指标
主要结局
Safety Composite
时间窗: 30 days, 6 months
Composite of amputation free survival, defined as the rate of limb salvage (freedom from major amputation) and survival (freedom from all causes of death) of the percutaneous deep foot venous arterialization procedure.
次要结局
- Freedom from all cause death(30 days, 3 months, 6 months, 12 months and 24 months)
- Primary Patency(30 days, 3 months, 6 months, 12 months and 24 months)
- Procedural Success(Day 1)
- Major amputation rates(30 days, 3 months, 6 months, 12 months and 24 months)
- Minor amputation rates(30 days, 3 months, 6 months, 12 months and 24 months)
- Secondary Patency(30 days, 3 months, 6 months, 12 months and 24 months)
- A-V fistula flow rate(30 days, 3 months, 6 months, 12 months and 24 months)
- Re-Treatment rate(30 days, 3 months, 6 months, 12 months and 24 months)
- Wound Size(Baseline, 30 days, 3 months, 6 months, 12 months and 24 months)
- TpcO2(Baseline, 30 days, 3 months, 6 months, 12 months and 24 months)
- WIFi class(Baseline, 30 days, 3 months, 6 months, 12 months and 24 months)
- Freedom from procedure-related death(30 days, 3 months)
- Rutherford class(Baseline, 30 days, 3 months, 6 months, 12 months and 24 months)