Pilot Study of BAO-G Technique in TAAA Endovascular Repair

Early Phase 1

• Conditions: Aortic Aneurysm, Thoracoabdominal
• Interventions: Procedure: BAO-G

• Registration Number: NCT06534281
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2024-07-29
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-01
• Last Update Submitted: 2024-08-01
• Study First Posted: 2024-08-02
• Last Update Posted: 2024-08-02
• Primary Completion: 2030-12-31
• Study Completion: 2035-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BAO-G group	BAO-G	-

Primary Outcome Measures

Name	Time	Method
Rate of visceral branch patency	Month 0, 3, 6, 12, and annually after surgery	the patency of visceral branches measured by radiological test
Incidence of endoleak	Month 0, 3, 6, 12, and annually after surgery	The incidence of endoleak measured by radiological test
Incidence of re-operation	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 Outcome Measures

Name	Time	Method
Incidence of acute liver function injury	perioperative period	The incidence of acute liver function injury, measured by serum transaminase level
Incidence of acute pancreatitis	perioperative period	The incidence of acute pancreatitis, measured by serum amylase level
Incidence of organ ischemia	Month 0, 3, 6, 12, and annually after surgery	Incidence of organ ischemia, measured by physical examination and radiological test
Incidence of acute kidney injury	perioperative period	The incidence of acute kidney injury, measured by serum creatinine level

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China