Aortic Aneurysm, ThoracoabdominalEarly Phase 1NCT06534281
Pilot Study of BAO-G Technique in TAAA Endovascular Repair
A Early Phase 1 study testing BAO-G in people with Aortic Aneurysm, Thoracoabdominal, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Aneurysm, Thoracoabdominal
- What is being tested?
- BAO-G
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2035
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with TAAA, confirmed by aortic CTA.
- TAAA diameter ≥ 6cm, or symptomatic TAAA with diameter ≥ 4cm.
- Informed consent signed.
Who cannot join
- were pregnant.
- had a history of previous endovascular or open repair.
- had other contraindications of endovascular treatment.
- Uncontrolled autoimmune disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Aortic Aneurysm, Thoracoabdominal
- Being tested
- BAO-G
- Keywords
- BAO-G technique, thoracoabdominal aortic aneurysm, iliac-branched devices, endovascular repair
- Medical subject headings
- Aortic Aneurysm, Thoracoabdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAO-GProcedure or surgery
Using G-iliac system to reconstruct the visceral branches of in endovascular repair of thoracoabdominal aortic aneurysm.
| Study group | Role | What they receive |
|---|---|---|
| BAO-G group | Experimental | Not described Receives: Procedure: BAO-G |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of visceral branch patency
the patency of visceral branches measured by radiological test
Measured: Month 0, 3, 6, 12, and annually after surgery
Incidence of endoleak
The incidence of endoleak measured by radiological test
Measured: Month 0, 3, 6, 12, and annually after surgery
Incidence of re-operation
The incidence of re-operation for any adverse events, confirmed by medical record and outpatient follow up
Measured: Month 0, 3, 6, 12, and annually after surgery
Secondary outcomes (4)
Incidence of organ ischemia
Incidence of organ ischemia, measured by physical examination and radiological test
Measured: Month 0, 3, 6, 12, and annually after surgery
Incidence of acute kidney injury
The incidence of acute kidney injury, measured by serum creatinine level
Measured: perioperative period
Incidence of acute liver function injury
The incidence of acute liver function injury, measured by serum transaminase level
Measured: perioperative period
Incidence of acute pancreatitis
The incidence of acute pancreatitis, measured by serum amylase level
Measured: perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Jan 2022
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, ThoracoabdominalStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Bao, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534281
- Sponsor's protocol ID
- BAO-G-01
- Status last verified
- Aug 2024
- First submitted
- 29 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Multi-Branch AOrtic Reconstruction With G-iliac System (BAO-G) Technique in Thoracoabdominal Aortic Aneurysm Endovascular Repair
- ClinicalTrials.gov ID
- NCT06534281
- Acronym / sponsor ID
- BAO-G-01
- Conditions
- Aortic Aneurysm, Thoracoabdominal
- Keywords
- BAO-G technique, thoracoabdominal aortic aneurysm, iliac-branched devices, endovascular repair
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BAO-G group | Experimental | Procedure: BAO-G |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with TAAA, confirmed by aortic CTA.
- TAAA diameter ≥ 6cm, or symptomatic TAAA with diameter ≥ 4cm.
- Informed consent signed.
Key exclusion criteria (4 listed)
- were pregnant.
- had a history of previous endovascular or open repair.
- had other contraindications of endovascular treatment.
- Uncontrolled autoimmune disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAO-GUsing G-iliac system to reconstruct the visceral branches of in endovascular repair of thoracoabdominal aortic aneurysm. | Procedure or surgery | BAO-G group |
Primary outcome
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
Incidence of endoleak
Time frame: Month 0, 3, 6, 12, and annually after surgery
The incidence of endoleak measured by radiological test
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
4 secondary outcomes
Incidence of organ ischemia
Time frame: Month 0, 3, 6, 12, and annually after surgery
Incidence of acute kidney injury
Time frame: perioperative period
Incidence of acute liver function injury
Time frame: perioperative period
Incidence of acute pancreatitis
Time frame: perioperative period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing BAO-G in people with Aortic Aneurysm, Thoracoabdominal, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of visceral branch patency (time frame: Month 0, 3, 6, 12, and annually after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.