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Enrolling by Invitation

NCT Number: NCT06534281

Pilot Study of BAO-G Technique in TAAA Endovascular Repair

Multi-Branch AOrtic Reconstruction With G-iliac System (BAO-G) Technique is a novel technique of endovascular repair of thoracoabdominal aortic aneurysm, which using off-the-shelf iliac branched devices to reconstruct the visceral branches. This study aims to evaluate the safety and efficacy of BAO-G in thoracoabdominal aortic aneurysm endovascular repair.

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Key information

Conditions

Aortic Aneurysm, Thoracoabdominal Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Peking Union Medical College Hospital

Beijing, 100730, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with TAAA, confirmed by aortic CTA.
  • TAAA diameter ≥ 6cm, or symptomatic TAAA with diameter ≥ 4cm.
  • Informed consent signed.

Exclusion criteria

  • were pregnant.
  • had a history of previous endovascular or open repair.
  • had other contraindications of endovascular treatment.
  • Uncontrolled autoimmune disease.

Treatment and study plan

BAO-G

Procedure

Using G-iliac system to reconstruct the visceral branches of in endovascular repair of thoracoabdominal aortic aneurysm.

Primary outcomes

  1. Rate of visceral branch patency

    Time frame: Month 0, 3, 6, 12, and annually after surgery

    the patency of visceral branches measured by radiological test

  2. Incidence of endoleak

    Time frame: Month 0, 3, 6, 12, and annually after surgery

    The incidence of endoleak measured by radiological test

  3. Incidence of re-operation

    Time frame: Month 0, 3, 6, 12, and annually after surgery

    The incidence of re-operation for any adverse events, confirmed by medical record and outpatient follow up

Secondary outcomes

  1. Incidence of organ ischemia

    Time frame: Month 0, 3, 6, 12, and annually after surgery

    Incidence of organ ischemia, measured by physical examination and radiological test

  2. Incidence of acute kidney injury

    Time frame: perioperative period

    The incidence of acute kidney injury, measured by serum creatinine level

  3. Incidence of acute liver function injury

    Time frame: perioperative period

    The incidence of acute liver function injury, measured by serum transaminase level

  4. Incidence of acute pancreatitis

    Time frame: perioperative period

    The incidence of acute pancreatitis, measured by serum amylase level

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Pilot Study of Multi-Branch AOrtic Reconstruction With G-iliac System (BAO-G) Technique in Thoracoabdominal Aortic Aneurysm Endovascular Repair

Important dates

Study start
2022
Primary completion
2030
Study completion
2035
First posted
Aug 2, 2024
Registry last updated
Aug 2, 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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