Expert Survey, Interactive Case Planning, and Modified Delphi Consensus: A Comprehensive Approach to Define Standards for Physician-Modified Stent Grafts in the Treatment of Abdominal Aortic Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Expert Consensus on PMSG Indications and Techniques
研究概览
简要总结
This study explores the use of physician-modified stent grafts (PMSGs) for treating abdominal aortic aneurysms that are unsuitable for open surgery or standard endovascular grafts. Custom-made fenestrated endografts are not viable in urgent or symptomatic cases due to lengthy manufacturing times. Although off-the-shelf branched devices are more readily available, they present challenges such as high costs, extensive thoracic coverage, limited long-term data, and anatomical restrictions. Parallel graft techniques are also associated with concerns regarding their durability. PMSG procedures, however, are not standardized and rely heavily on the physician's experience and expertise. The aim of this comprehensive study is to establish expert consensus on the indications, planning protocols, and procedural techniques for PMSGs.
详细描述
Principal Investigator: Dr. med. Giorgio Prouse
Ethics: The study was presented to the Ethics Committee of Canton Ticino, where formal approval was waived.
Background Physician-modified stent grafts (PMSGs) are increasingly used to treat urgent cases of symptomatic abdominal aortic aneurysms that are unfit for open surgery and cannot be treated with a standard endovascular graft. In symptomatic patients, custom-made fenestrated endografts are not an option due to the manufacturing time required. Recently, some off-the-shelf branched devices that allow for the treatment of many aneurysms involving the visceral aorta have been made available. However, these devices have significant shortcomings, including high cost, the need for extended thoracic aortic coverage, limited long-term outcome data, and the inability to treat certain anatomies. Parallel graft techniques have also been used for treating complex and urgent cases, yet the effectiveness and durability of aneurysm exclusion remain concerns. In such scenarios, PMSGs serve as a legitimate off-label alternative. However, the variety of techniques and strategies outlined by multiple study groups underscores the critical necessity for procedural standardization to mitigate the potential risks of life-threatening procedural errors.
Objective The study aims to establish a foundation for defining standards for PMSG procedures, including indications, optimal planning protocols, and the most established procedural techniques.
Primary Endpoint: To achieve expert consensus on aspects regarding indications, planning, and performing PMSGs in the treatment of abdominal aortic aneurysms, as determined by the completion of a modified Delphi consensus.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Vascular Surgeons or Interventional Radiologists
- •Must have expertise in fenestrated, branched, and PMSG procedures.
- •Completed the 31-question survey via the EDDDIE platform.
- •Informed consent is required for participation.
排除标准
- •Physicians with no complex endovascular repair experience
结局指标
主要结局
Expert Consensus on PMSG Indications and Techniques
时间窗: 30.06.2025
The expert consensus will be reached using the Delphi method (following CREDES guidelines), with three rounds planned. Consensus will be defined based on a Likert scale (1-5): * Very high consensus: median = 5 and percentage agreement ≥ 80%, IQR = 0; * High consensus: median = 4/5, percentage agreement ≥ 80%, IQR = 0; * Moderate consensus: median ≥ 4; 60%-79% agreement, IQR = 1; * Low consensus: median rating \< 4, \<60% agreement, IQR \> 1
次要结局
- Survey-Based Review of PMSG Strategies and Techniques(30.06.2025)
- Comparison of 3D-Printed Models and CT-Based Planning(30.06.2025)