Use of Three-Dimensional Printed Models for Endovascular Planning and Follow-up in Patients Affected by Aorto-Iliac-Femoral-Popliteal Arterial Disease Undergoing Balloon Angioplasty: Applicability, Effectiveness in Technical Success and on Mid-Term Outcomes, Cost-Analysis, and Exploration of New Technologies. A Single-center, Single-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Confirm the effectiveness of 3D-printed models for the preoperative planning of aorto-iliac-femoral-popliteal PTA
研究概览
简要总结
Lower extremity peripheral arterial disease is a major health problem. Currently, balloon angioplasty represents the most commonly performed treatment for patients affected by vascular claudication or critical limb ischemia. Pre-operative planning for aorto-iliac-femoral-popliteal atherosclerotic disease is a complex procedure, since an inappropriate strategy may lead to peri-operative complications. The aim of this study is to propose an innovative planning strategy for balloon angioplasty with the support of complex 3D printed models. The goal is to reduce peri-operative complications and overall costs, while improving technical success and mid-term patency of revascularizations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 89 years;
- •Severe claudication or critical limb ischemia (Rutherford categories 3-5 [Cronenwett and Johnston. Rutherford's Vascular Surgery 7th edition. Saunders Elsevier 2010]) and indication already established for endovascular revascularization treatment (according to the current Italian SICVE guidelines);
- •Atherosclerotic disease involving the aorto-iliac-femoro-popliteal segment;
- •Signed informed consent.
排除标准
- •Age <18 years or >89 years;
- •Preoperative CTA not available for any reason (clinical contraindication, logistical impossibility);
- •Patients requiring urgent intervention (lack of time for 3D model printing);
- •Atherosclerotic disease limited to tibial vessels only (absent or non-significant atherosclerosis at aorto-iliac-femoro-popliteal level);
- •Patient refusal to participate in the study.
研究组 & 干预措施
Preoperative planning performed based on CTA (standard of care)
干预措施: PTA (Standard of Care) (Device)
Preoperative planning performed using CTA and a patient-specific, custom-made 3D-printed model
干预措施: PTA planning supported by 3D-printed model (Device)
结局指标
主要结局
Confirm the effectiveness of 3D-printed models for the preoperative planning of aorto-iliac-femoral-popliteal PTA
时间窗: From treatment to the end of the post-operative period (30 days)
次要结局
- Determine the usefulness of 3D-printed models in the mid-term and during follow-up after PTA(From 1-month follow-up to 18-month follow-up)
研究者
Paolo Perini
Professor
Azienda Ospedaliero-Universitaria di Parma