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临床试验/NCT03824730
NCT03824730已完成不适用

Endovascular Treatment of Different Types of Aorto-iliac Occlusions

Clinical Centre of Serbia2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Primary artery/stent patency rate

研究概览

简要总结

This study compares early and long-term results of the endovascular treatment among patients with different types of aorto-iliac occlusions.

详细描述

Endovascular treatment has been increasingly applied as a therapeutic option for aorto-iliac occlusive disease during the last decade, becoming the first-line treatment for many of the Trans-Atlantic Inter-Society Consensus document II (TASC II) categories. TASC II document in 2007 stated endovascular treatment as the method of choice up to type B occlusions and surgery for low-risk patients with type C and D occlusions, emphasizing that the patient's comorbidities as well as the operator's long-term success rates should be included in the decision-making process.

Revision of TASC II document in 2015 is suggesting that the preferred revascularization method should be based on each vascular center's competence and experience with the anatomic complexity, considering patient comorbidity and overall prognosis, supporting the endovascular-first approach in all 4 different kinds of lesions in highly experienced centers.

These changes over time are based on expert opinions derived from smaller studies from high volume centers, and that they reflect both the widespread gain of endovascular experience and technical developments over the last 2 decades, leading to a rising number of centers providing an endovascular-first approach even in complex TASC C and D occlusions.

Rationale for offering endovascular-first option to patient with complex lesion would be low risk of complication and long-term patency.

Our intention is to compare early and long-term results of the endovascular treatment among patients with different types of aorto-iliac occlusions in two Serbian vascular centres.

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

入选标准

  • Patient has aorto-iliac occlusions type B, C & D according to TASC-II classification
  • Patient suffers from severe claudication (Rutherford 3) or critical limb ischemia (Rutherford 4 and 5)
  • Patients fulfilling criteria for endovascular treatment of aorto-iliac occlusion according to criteria of the participating centres.

排除标准

  • Patients with associated abdominal or iliac aneurysm, restenotic lesions, acute thrombi or dissections,
  • Patients who experienced an initial technical failure

结局指标

主要结局

Primary artery/stent patency rate

时间窗: 60 Months

Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation.

次要结局

  • Primary assisted artery/stent patency rate(60 months)
  • Clinical success(60 months)
  • Number of participants with periprocedural complications: hematoma, bleeding, pseudoaneurysm, renal failure, myocardial infarction, stroke, mortality, thrombosis of the treated segment(1 month)
  • Secondary patency artery/stent rate(60 months)

研究者

发起方
Clinical Centre of Serbia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Vladimir Cvetic

Principal Investigator

Clinical Centre of Serbia

研究点 (2)

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