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临床试验/NCT07096388
NCT07096388招募中不适用

Evaluation Of Cost-Effectiveness Of Iliac Branch Endoprostheses: A Multi-Center, Retrospective-Prospective, Observational Study/ Eunet-Hta Core Model

Prof. Andrea Kahlberg1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2026年4月28日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
1
主要终点
Comparison of perioperative and late clinical success

研究概览

简要总结

The study is a multi-center, voluntary observational study on an ambispective cohort of patients treated between January 2018 and December 2025.The study aims to enroll 300 patients (around 200 patients in the retrospective cohort and 100 patients in the prospective cohort). The study will include adult patients (≥ 18 years) of either sex submitted to open surgical repair or endovascular repair of an aorto-iliac aneurysm.The procedures and clinical evaluation included in this study correspond to current clinical practice. The assignment of the patient to a given diagnostic and/or therapeutic procedure is not linked to random allocation but is part of the ordinary therapeutic strategy provided for that patient; full freedom of choice as regards to the allocation of the patient to the diagnostic and therapeutic procedures is guaranteed for each case. Follow-up visits substantially correspond to current clinical practice or to the requirements of national and/or international guidelines. The administration of questionnaires, interviews, diaries, surveys of health economics and pharmacoeconomics, subjective assessments by the patient on their state of health, assessment scales and blood chemistry tests, the use of which is justified by the rationale of the study. The objectives of the study are the comparison of perioperative and late clinical success of repair procedure and comparison of cost-effectiveness of two precedures.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

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

入选标准

  • Patients affected by an aorto-iliac aneurysm who received an elective open surgical repair (aneurysmectomy and aortic reconstruction with a surgical graft) or endovascular repair (with Iliac Branch Endoprosthesis)
  • Adult patients ≥18 years
  • Patients able to understand and sign the informed consent approved by the Ethics Committee of San Raffaele Hospital

排除标准

  • Patients treated with a hybrid approach (concomitant open surgical and endovascular treatment)
  • Patients treated with other endovascular techniques besides branched technology (e.g., physician-modified endografts, parallel grafts)
  • Patients already submitted to prior open or endovascular repair for aorto-iliac aneurysm/prior aorto iliac aneurysm sac embolization
  • Patients treated in urgent/emergent setting

研究组 & 干预措施

Endovascular repair

Patients affected by an aorto-iliac aneurysm who received endovascular repair (with Iliac Branch Endoprosthesis)

干预措施: endovascular repair (Procedure)

Open surgical repair

Patients affected by an aorto-iliac aneurysm who received an elective open surgical repair (aneurysmectomy and aortic reconstruction with a surgical graft)

干预措施: open surgical repair (Procedure)

结局指标

主要结局

Comparison of perioperative and late clinical success

时间窗: 30 days 1 year 2 years

Analysis of physiological parameters as Freedom from aorto-iliac related death, major adverse events (MAEs), and reintervention

Comparison of perioperative and late clinical success

时间窗: 30 days 1 year 2 years

Analysis of physiological parameters as Freedom from aorto-iliac related death, major adverse events (MAEs), and reintervention

次要结局

  • Comparison of cost-effectiveness(30 days 1 year 2 years)
  • Comparison of cost-effectiveness(30 days 1 year 2 years)

研究者

发起方
Prof. Andrea Kahlberg
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prof. Andrea Kahlberg

Prof.

IRCCS San Raffaele

研究点 (1)

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