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

NCT07697820 | Not Yet Recruiting

• 1 other identifier: TEVAR
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Aortic Aneurysm and Dissection

Outcome Measures

Primary Outcomes (2)

• Number of participants achieving technical success

  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.

  30 days

• Number of participants experiencing perioperative complications or requiring reintervention

  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.

  30 days

Secondary Outcomes (3)

• 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

Study Arms (2)

Surgery

ACTIVE COMPARATOR

Bypass

Procedure: Bypass graft

Endovascular

ACTIVE COMPARATOR

Branched endograft

Procedure: Bypass graft

Interventions

Bypass graft PROCEDURE

Carotid subclavian bypass

Endovascular; Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• 1. Feezor RJ, Martin TD, Hess PJ, Klodell CT, Beaver TM, Huber TS, et al. Risk factors for perioperative stroke during thoracic endovascular aortic repairs (TEVAR). J Endovasc Ther. 2007 Aug;14(4):568-73. doi:10.1177/152660280701400420 PubMed PMID: 17696634. 2. Matsumura JS, Lee WA, Mitchell RS, Farber MA, Murad MH, Lumsden AB, et al. The Society for Vascular Surgery Practice Guidelines: management of the left subclavian artery with thoracic endovascular aortic repair. J Vasc Surg. 2009 Nov;50(5):1155-8. doi:10.1016/J.JVS.2009.08.090 PubMed PMID: 19878791. 3. Wanhainen A, Gombert A, Antoniou GA, Fidalgo Domingos LA, Gouveia e Melo R, Grabenwöger M, et al. European Society for Vascular Surgery (ESVS) 2026 Clinical Practice Guidelines on the Management of Descending Thoracic and Thoraco-Abdominal Aortic Diseases. European Journal of Vascular and Endovascular Surgery. 2025 Feb 1;71(2):172-270. doi:10.1016/J.EJVS.2025.12.050/ATTACHMENT/4919EBC3-7A5C-48FD-9138-D4C9AB08CE0D/MMC3.PDF PubMed PMID: 41448425. 4. Upchurch GR, Escobar GA, Azizzadeh A, Beck AW, Conrad MF, Matsumura JS, et al. Society for Vascular Surgery clinical practice guidelines of thoracic endovascular aortic repair for descending thoracic aortic aneurysms. J Vasc Surg. 2021 Jan 1;73(1):55S-83S. doi:10.1016/J.JVS.2020.05.076/ASSET/A831C192-C4DD-4DCB-9701-3DD23F180CA0/MAIN.ASSETS/GR2.JPG PubMed PMID: 32628988. 5. Lin F, He Z, Gao J, Huang X, Wang H, Han L, et al. Comparison of surgical and endovascular left subclavian artery revascularization during thoracic aortic endovascular repair: a systematic review and meta-analysis. Front Cardiovasc Med. 2023 Nov 2;10:1274629. doi:10.3389/FCVM.2023.1274629/TEXT 6. Scali ST, Chang CK, Pape SG, Feezor RJ, Berceli SA, Huber TS, et al. Subclavian revascularization in the age of thoracic endovascular aortic repair and comparison of outcomes in patients with occlusive disease. J Vasc Surg. 2013 Oct;58(4):901-9. doi:10.1016/J.JVS.2013.04.005 PubMed PMID: 23711694.

  BACKGROUND

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 13, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 13, 2026

Record last verified: 2026-06