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Not yet recruiting NCT06256757

Safety and Validity of Extracorporeal Fenestration and in Situ Fenestration in Patients With Aortic Disease Involving the Left Subclavian Artery

No phase Interventional Aortic Dissection Aneurysm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: fenestration.
Who it may be relevant to
Registry conditions: Aortic Dissection Aneurysm. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure fenestration
    Thoracic EndoVascular Aortic Repair (TEVAR) with fenestrations

Primary outcome measures

  • all-cause mortality [Time frame: 1 month postoperative]
Secondary outcome measures (5)
  • incidence of endoleak [Time frame: postoperative (1, 6，12 months)]
  • incidence of secondary intervention [Time frame: postoperative (1, 6，12 months)]
  • incidence of major adverse events (MAE) [Time frame: postoperative (1, 6，12 months)]
  • immediate technical success rate [Time frame: immediate postoperative]
  • all-cause mortality [Time frame: postoperative (6, 12 months)]

Eligibility criteria

Inclusion Criteria:(All of the following criteria were met for enrolment):

  • Patients aged greater than 18 years old and less than 80 years old.
  • Patients diagnosed with thoracic aortic disease, including thoracic aortic dissection, thoracic aortic aneurysm, thoracic aortic ulcer and intramural hematoma.
  • Patients needed endovascular repair (TEVER).
  • Patients who needed complete coverage of the left subclavian artery (planned landing Zone was in Zone 2 of the aortic zone).
  • The proximal lesion involved the proximal aorta within 1.5cm of the posterior edge of the left subclavian artery (LSA) opening, but not the left common carotid artery (LCCA).
  • Suitable femoral artery, iliac artery and brachial artery access can be used for endovascular treatment.
  • The patients could understand the purpose of the study, volunteered to participate in the study, and informed consent was signed by the subjects themselves or their legal representatives.
  • Patients were willing to undergo follow-up evaluation as required by the study protocol.
  • The life expectancy of the patient is more than 12 months.

Exclusion Criteria:(If any of the following criteria is met):

  • The lesion involved the proximal aorta of the LCCA opening (Zone 0 and Zone 1).
  • The patient has a definite connective tissue disease (e.g., Marfan syndrome).
  • The subjects had a history of previous thoracic endovascular aortic repair (TEVAR).
  • Patients who have had or may have had severe allergic reactions to contrast media (anaphylactic shock, exfoliative dermatitis, etc.).
  • Patients with contraindications to antiplatelet and anticoagulant drugs.
  • The patient's compliance was poor and the follow-up could not be expected on time.
  • Patients with acute systemic infection.
  • Patients cannot tolerate general anesthesia.
  • Patients judged by the investigator to be ineligible for endovascular treatment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Jia X, Wu J, Ding C, Lou Y. Safety and validity of extracorporeal fenestration and in situ fenestration in patients with aortic disease involving the left subclavian artery: a prospective, single-center, randomized controlled study. Trials. 2025 Jan 30;26(1):33. doi: 10.1186/s13063-025-08746-5. PMID 39885531

Identifiers

NCT: NCT06256757 · K2024031

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗