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Enrolling by invitation NCT06534281

Pilot Study of BAO-G Technique in TAAA Endovascular Repair

Early Phase I Interventional Aortic Aneurysm, Thoracoabdominal

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: BAO-G.
Who it may be relevant to
Registry conditions: Aortic Aneurysm, Thoracoabdominal. 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
China
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 →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Rate of visceral branch patency [Time frame: Month 0, 3, 6, 12, and annually after surgery]
  • Incidence of endoleak [Time frame: Month 0, 3, 6, 12, and annually after surgery]
  • Incidence of re-operation [Time frame: Month 0, 3, 6, 12, and annually after surgery]
Secondary outcome measures (4)
  • Incidence of organ ischemia [Time frame: Month 0, 3, 6, 12, and annually after surgery]
  • Incidence of acute kidney injury [Time frame: perioperative period]
  • Incidence of acute liver function injury [Time frame: perioperative period]
  • Incidence of acute pancreatitis [Time frame: perioperative period]

Eligibility criteria

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.

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

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking Union Medical College Hospital — Beijing

Identifiers

NCT: NCT06534281 · BAO-G-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗