Key result
RCT protocol evaluates if extracorporeal fenestration is non-inferior to in situ fenestration for 30-day mortality.
Why the study?
Maintaining supra-aortic branch patency while excluding arch lesions remains challenging, and the comparative safety and validity of extracorporeal versus in situ fenestration during TEVAR are unclear.
Does extracorporeal fenestration improve all-cause mortality compared to in situ fenestration in patients with aortic disease involving the left subclavian artery undergoing TEVAR?
RCT (n=170)
Single-blind
1:1
No
Does extracorporeal fenestration improve all-cause mortality compared to in situ fenestration in patients with aortic disease involving the left subclavian artery undergoing TEVAR?
This trial protocol aims to assess the safety and validity of extracorporeal versus in situ fenestration during TEVAR for aortic disease involving the left subclavian artery.
May support fenestrated TEVAR in select arch cases; hypothesis-generating and requires RCTs before practice change.
BACKGROUND: Thoracic aortic pathologies involving the aortic arch are a great challenge for vascular surgeons. Maintaining the patency of supra-aortic branches while excluding the aortic lesion remains difficult. Thoracic EndoVascular Aortic Repair (TEVAR) with fenestrations provides a feasible and effective approach for this type of disease. The main purpose of this trial is to assess the safety and validity of extracorporeal fenestration and in situ fenestration in patients with aortic disease involving the left subclavian artery. METHODS: This is a prospective, single-center, randomized controlled study. A total of 170 eligible patients will be recruited from The Fourth Affiliated Hospital, Zhejiang University School of Medicine in China and randomized on a 1:1 basis either to the group A (extracorporeal fenestration) or the group B (in situ fenestration). The primary outcome will be the all-cause mortality (30 days). The secondary outcomes will include incidence of secondary intervention (30 days, 6 months, 1 year), incidence of endoleak (30 days, 6 months, 1 year), incidence of major adverse events (MAE) (i.e., immediate procedural success and complications) (30 days, 6 months, 1 year), immediate technical success rate, and all-cause mortality (6 months, 1 year). DISCUSSION: Suppose extracorporeal fenestration non-inferior to in situ fenestration in patients with aortic disease involving the left subclavian artery. This trial aims to demonstrate the safety and validity of extracorporeal fenestration and in situ fenestration in patients with aortic disease involving the left subclavian artery, which is expected to provide a reference for Thoracic EndoVascular Aortic Repair (TEVAR) with fenestrations. TRIAL REGISTRATION: ClinicalTrials.gov NCT06256757. Registered on February 5, 2024. https://clinicaltrials.gov/study/NCT06256757 .
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Jia et al. (2025) conducted an RCT in Aortic disease involving the left subclavian artery (n=170). Extracorporeal fenestration vs. In situ fenestration was evaluated on All-cause mortality at 30 days. This study protocol outlines a randomized controlled trial to evaluate whether extracorporeal fenestration is non-inferior to in situ fenestration for 30-day all-cause mortality in patients with aortic disease involving the left subclavian artery.
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