Not Yet RecruitingNot Applicable

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

170 participantsStarted 2024-05-01

Plain-language summary

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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

all-cause mortality

Timeframe: 1 month postoperative

Trial details

NCT IDNCT06256757

SponsorThe Fourth Affiliated Hospital of Zhejiang University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-05-30

Contact for this trial

Yanbo Lou

15088201610 yanbo_lou@zju.edu.cn

View on ClinicalTrials.gov More Aortic Dissection Aneurysm trials