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NCT Number: NCT06256757

Safety and Validity of Extracorporeal Fenestration and 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fenestration

Procedure

Thoracic EndoVascular Aortic Repair (TEVAR) with fenestrations

Primary outcomes

  1. all-cause mortality

    Time frame: 1 month postoperative

    all-cause mortality

Secondary outcomes

  1. incidence of endoleak

    Time frame: postoperative (1, 6,12 months)

    incidence of endoleak

  2. incidence of secondary intervention

    Time frame: postoperative (1, 6,12 months)

    incidence of secondary intervention

  3. incidence of major adverse events (MAE)

    Time frame: postoperative (1, 6,12 months)

    incidence of major adverse events (MAE)

  4. immediate technical success rate

    Time frame: immediate postoperative

    immediate technical success rate

  5. all-cause mortality

    Time frame: postoperative (6, 12 months)

    all-cause mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Yanbo Lou

CONTACT

[email protected]

15088201610

Sponsors and collaborators

Lead sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Other

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Feb 13, 2024
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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