Pilot Study of BAO-G Technique in TAAA Endovascular Repair

August 1, 2024 updated by: Liu Bao, Peking Union Medical College Hospital

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100730
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BAO-G group
Procedure: BAO-G
Using G-iliac system to reconstruct the visceral branches of in endovascular repair of thoracoabdominal aortic aneurysm.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2035

Study Registration Dates

First Submitted

July 29, 2024

First Submitted That Met QC Criteria

August 1, 2024

First Posted (Actual)

August 2, 2024

Study Record Updates

Last Update Posted (Actual)

August 2, 2024

Last Update Submitted That Met QC Criteria

August 1, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAO-G-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aortic Aneurysm, Thoracoabdominal

Clinical Trials on BAO-G

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe