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Enrolling by invitationNCT06534281Updated Aug 2, 2024

Pilot Study of BAO-G Technique in TAAA Endovascular Repair

An Early Phase 1 interventional study of BAO-G in Aortic Aneurysm, Thoracoabdominal, sponsored by Peking Union Medical College Hospital. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-08-02.

Sponsored by Peking Union Medical College Hospital · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Jan 2022, registered Jul 2024).
Phase
Early Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
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Study summary

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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Conditions studied

  • Aortic Aneurysm, Thoracoabdominal

Keywords

  • BAO-G technique
  • thoracoabdominal aortic aneurysm
  • iliac-branched devices
  • endovascular repair
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In context

Aneurysm

960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.

This study's planned enrollment of 20 is below the median of 72 across 462 interventional studies indexed under Aneurysm.

Browse Aneurysm studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. were pregnant.
  2. had a history of previous endovascular or open repair.
  3. had other contraindications of endovascular treatment.
  4. Uncontrolled autoimmune disease.
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Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    BAO-G group

    Procedure: BAO-G

Interventions

  • ProcedureBAO-G

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

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What researchers measure

Primary outcomes

  1. Rate of visceral branch patency

    the patency of visceral branches measured by radiological test

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

  2. Incidence of endoleak

    The incidence of endoleak measured by radiological test

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

  3. Incidence of re-operation

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

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

Secondary outcomes

  1. Incidence of organ ischemia

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

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

  2. Incidence of acute kidney injury

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

    Time frame: perioperative period

  3. Incidence of acute liver function injury

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

    Time frame: perioperative period

  4. Incidence of acute pancreatitis

    The incidence of acute pancreatitis, measured by serum amylase level

    Time frame: perioperative period

07

Study locations

1 site
  • Peking Union Medical College Hospital
    Beijing, 100730, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06534281
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Liu Bao (Professor, Peking Union Medical College Hospital) — Principal investigator
First posted
Aug 2, 2024
Start date
Jan 1, 2022
Primary completion
Dec 31, 2030 (estimated)
Completion
Dec 31, 2035 (estimated)
Last update
Aug 2, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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