Multicenter, Open-labeled, Single-arm Clinical Trial of Multi-Branch AOrtic Reconstruction of Complex Aortic Aneurysm With G-iliac System [BAO-G] Technique

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

Multi-Branch AOrtic Reconstruction With G-iliac System (BAO-G) Technique is a novel technique of endovascular repair of complex aortic aneurysm, which using off-the-shelf iliac branched devices to reconstruct the visceral branches. This study aims to verify the perioperative safety and 5-year efficacy of BAO-G technique in the endovascular treatment of complex aortic aneurysms through a prospective, multicenter, open-label, single-arm clinical trial, and to provide evidence for the selection of clinical procedures for complex aortic aneurysm patients in the future.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Diagnosed with Crawford type III-IV thoracoabdominal aortic aneurysm or complex abdominal aortic aneurysm, with a healthy proximal landing zone (\>20mm length, angulation \<60°) in the descending aorta and maximum aneurysm diameter ≥4cm

• Scheduled for endovascular aortic repair with commercially available iliac branch devices for visceral artery reconstruction

• Signed informed consent and committed to protocol-defined follow-up

Locations
Other Locations
China
Beijing Anzhen Hospital, Capital Medical University
RECRUITING
Beijing
Fuwai Hospital, CAMS&PUMC
RECRUITING
Beijing
Peking Union Medical College Hospital
RECRUITING
Beijing
The First Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
The First Affiliated Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Hainan General Hospital
RECRUITING
Haikou
The Affiliated Hospital of Jining Medical University
RECRUITING
Jining
Changhai Hospital
RECRUITING
Shanghai
Renji Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Zhongshan Hospital, Fudan University
RECRUITING
Shanghai
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Bao Liu
liubao7286@163.com
+86010-69152592
Time Frame
Start Date: 2022-01-01
Estimated Completion Date: 2035-12-31
Participants
Target number of participants: 60
Treatments
Experimental: BAO-G group
Related Therapeutic Areas
Sponsors
Collaborators: Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing Anzhen Hospital, First Affiliated Hospital of Chongqing Medical University, The First Affiliated Hospital of Zhengzhou University, Hainan General Hospital, RenJi Hospital, Fudan University, First Affiliated Hospital, Sun Yat-Sen University, The Affiliated Hospital of Jining Medical University, Changhai Hospital
Leads: Peking Union Medical College Hospital

This content was sourced from clinicaltrials.gov