Pilot Study of BAO-G Technique in TAAA Endovascular Repair

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Invitation-only; Early Phase 1

Conditions: Aortic Aneurysm, Thoracoabdominal

Treatments: Procedure: BAO-G

Study type: Interventional

Funder types: Other

Identifiers

NCT06534281

BAO-G-01

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

BAO-G group

Experimental group

Treatment:

Procedure: BAO-G