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临床试验/NCT07697820
NCT07697820尚未招募不适用

Outcomes of Left Subclavian Artery Revascularization Strategies During Zone 2 Thoracic Endovascular Aortic Repair

Assiut University0 个研究点目标入组 50 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
Number of participants achieving technical success

研究概览

简要总结

Intentional coverage of left subclavian artery (LSA) is often necessary during thoracic endovascular aortic repair (TEVAR) to secure an adequate proximal landing zone. However, this may impair blood flow to vital vascular territories with increased risk of stroke, spinal cord ischemia and upper limb ischemia.

Current recommendations from the Society for Vascular Surgery (SVS) and European Society for Vascular Surgery (ESVS) support the consideration of LSA revascularization in patients undergoing elective TEVAR with anticipated LSA coverage. In contrast, management in the acute setting is more complex and requires an individualized approach based on clinical urgency and anatomical factors. Revascularization is generally recommended in high-risk clinical scenarios, including patients with dominant left vertebral circulation, compromised or occluded contralateral vertebral artery, an incomplete circle of Willis, or variant vertebral anatomy such as a hypoplastic left vertebral artery terminating in the posterior inferior cerebellar artery or an isolated vertebral artery. Additional indications include prior LIMA grafting, the presence of upper limb dialysis access, anticipated extensive aortic coverage, or an aberrant right subclavian artery in which both subclavian origins may be compromised.

Revascularization techniques encompass both open surgical and endovascular approaches. Surgical options include carotid-subclavian bypass, carotid-axillary bypass, and subclavian transposition, while endovascular methods involve branched or fenestrated endografts, chimney and periscope grafts, as well as in situ fenestration. Although surgical techniques provide durable long-term patency, they are associated with a risk of local complications. Endovascular approaches are minimally invasive; however, they may be associated with an increased risk of endoleaks.

Anatomical factors also play a central role in determining both the feasibility and outcomes. Preoperative assessment using computed tomography angiography is essential to evaluate aortic arch morphology, proximal landing zone characteristics, branch vessel orientation, and access vessel suitability. In addition, the spatial relationship between the left common carotid artery (LCCA) and LSA, including minimum inter-vessel distances, directly influences the feasibility of branched or fenestrated endografts. Also branch vessel anatomy is equally critical, as LSA diameter, vertebral artery origin, and vessel length determine the suitability for branch incorporation or fenestration techniques. Furthermore, access-related anatomical constraints, particularly iliofemoral vessel diameter and calcification, may significantly limit device delivery.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Care Provider)

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 ≥18 years Undergoing TEVAR with proximal landing in zone 2 whether acute or chronic type B aortic dissection (TBAD), thoraco-abdominal aortic aneurysm (TAAA), penetrating aortic ulcer (PAU) or intramural hematoma (IMH).
  • Treatment with one of the following:
  • Single-branched stent grafts
  • In-situ fenestration (e.g. ISLF ± stent)
  • Chimney/periscope graft techniques
  • Physician-modified endografts (PMEGs)
  • Carotid-subclavian bypass, carotid-axillary bypass, or subclavian transposition

排除标准

  • • Non revascularized left subclavian artery.
  • Zone 0 or 1 procedures
  • Multi-vessel arch debranching
  • Blunt traumatic aortic injury (BTAI)
  • Incomplete imaging or follow-up data

研究组 & 干预措施

Surgery

Active Comparator

Bypass

干预措施: Bypass graft (Procedure)

Endovascular

Active Comparator

Branched endograft

干预措施: Bypass graft (Procedure)

结局指标

主要结局

Number of participants achieving technical success

时间窗: 30 days

Technical success is defined as successful stent graft deployment in the intended position with complete exclusion of the target aortic pathology, maintenance of left subclavian artery patency, absence of type I or III endoleak on completion angiography, and no intraoperative major adverse events (stroke, aortic rupture, or death). Results will be reported as the number and percentage of participants achieving technical success.

Number of participants experiencing perioperative complications or requiring reintervention

时间窗: 30 days

Perioperative outcomes include stroke, spinal cord ischemia, upper limb ischemia, myocardial infarction, access-related complications, aortic rupture, death, endoleak requiring treatment, and any unplanned surgical or endovascular reintervention occurring within 30 days after TEVAR. Results will be reported as the number and percentage of participants experiencing one or more events.

次要结局

  • Number of participants with primary left subclavian artery patency at 3 years(3 years)
  • Number of participants with assisted primary or secondary left subclavian artery patency(3 years)
  • Number of participants requiring left subclavian artery reintervention(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Tarek Mostafa

Assistant lecturer

Assiut University

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