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New stent technique aims to tame deadly aortic aneurysms without open surgery

NCT ID NCT07141251

Disease control Sponsor: Peking Union Medical College Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early-stage trial is testing a new procedure called BAO-G for people with complex aortic aneurysms (bulging of the main artery in the chest and abdomen). The technique uses off-the-shelf stent grafts to rebuild the artery's branches from inside the blood vessel, avoiding major open surgery. The study will enroll 60 participants across multiple centers to check if the procedure is safe and works well in the short and long term.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BAO-G procedure (using G-iliac system to reconstruct visceral branches during endovascular repair)
What this could lead to
If successful, this technique could offer a less invasive, safer option for repairing complex aortic aneurysms, reducing the need for open surgery.
What could go wrong
This is an early phase 1 trial with only 60 participants, so results are preliminary. The procedure carries risks like endoleak, branch occlusion, or aneurysm rupture.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2022

Expected to finish

Dec 2035

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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 2. Scheduled for endovascular aortic repair with commercially available iliac branch devices for visceral artery reconstruction 3. Signed informed consent and committed to protocol-defined follow-up Exclusion Criteria: 1. Acquired language barrier, intellectual decline, cognitive impairment, or mental illness preventing informed consent 2. Uncontrolled autoimmune diseases (e.g., Takayasu arteritis, systemic lupus erythematosus, vasculitis) 3. Prior aortic surgery with stent-graft or prosthetic vascular graft implantation 4. End-stage renal/hepatic/cardiac/pulmonary failure or malignancy diagnosed within 5 years, likely to cause mortality during follow-up 5. Active bleeding or coagulopathy within 6 months (high bleeding risk) 6. Uncontrolled hypertension (resting SBP \>180 mmHg or DBP \>110 mmHg) 7. Uncontrolled diabetes (fasting blood glucose \>16.7 mmol/L) 8. Severe hepatic/renal dysfunction (serum creatinine \>3 mg/dL, ALT/AST \>3×ULN) 9. Concurrent participation in other interventional clinical trials 10. Pregnancy or perinatal status 11. Refusal to sign informed consent

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Conditions

The condition(s) this trial relates to.

abdominal aortic aneurysm aortic aneurysm Aortic Aneurysm, Thoracoabdominal thoracic aortic aneurysm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Complex aortic aneurysms Endovascular repair Thoracoabdominal aortic aneurysm

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    11 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Anzhen Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 100029, China

  • Changhai Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200433, China

  • Fuwai Hospital, CAMS&PUMC

    RECRUITING

    Beijing, Beijing Municipality, 100037, China

  • Hainan General Hospital

    RECRUITING

    Haikou, Hainan, 570311, China

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100730, China

  • Renji Hospital, Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, 200127, China

  • The Affiliated Hospital of Jining Medical University

    RECRUITING

    Jining, Shandong, 272000, China

  • The First Affiliated Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, 400016, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, 450052, China

  • The First Affiliated Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, 510080, China

  • Zhongshan Hospital, Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

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