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New treatment option for Thoracoabdominal Aortic Aneurysm
Official title Clinical Trial of BAO-G Technique in Complex Aortic Aneurysm Endovascular Repair (BAO-G-02)
ClinicalTrials.gov ID: NCT07141251
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Diagnosed with Crawford type III-IV thoracoabdominal aortic aneurysm or complex abdominal aortic aneurysm, with a healthy proximal landing zone...
- 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
You likely can't join if
- Acquired language barrier, intellectual decline, cognitive impairment, or mental illness preventing informed consent
- Uncontrolled autoimmune diseases (e.g., Takayasu arteritis, systemic lupus erythematosus, vasculitis)
- Prior aortic surgery with stent-graft or prosthetic vascular graft implantation
- End-stage renal/hepatic/cardiac/pulmonary failure or malignancy diagnosed within 5 years, likely to cause mortality during follow-up
- Active bleeding or coagulopathy within 6 months (high bleeding risk)
- Uncontrolled hypertension (resting SBP \>180 mmHg or DBP \>110 mmHg)
See the full eligibility criteria
- 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...
- 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
- Acquired language barrier, intellectual decline, cognitive impairment, or mental illness preventing informed consent
- Uncontrolled autoimmune diseases (e.g., Takayasu arteritis, systemic lupus erythematosus, vasculitis)
- Prior aortic surgery with stent-graft or prosthetic vascular graft implantation
- End-stage renal/hepatic/cardiac/pulmonary failure or malignancy diagnosed within 5 years, likely to cause mortality during follow-up
- Active bleeding or coagulopathy within 6 months (high bleeding risk)
- Uncontrolled hypertension (resting SBP \>180 mmHg or DBP \>110 mmHg)
- Uncontrolled diabetes (fasting blood glucose \>16.7 mmol/L)
- Severe hepatic/renal dysfunction (serum creatinine \>3 mg/dL, ALT/AST \>3×ULN)
- Concurrent participation in other treatment clinical trials
- Pregnancy or perinatal status
- Refusal to sign informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Guangzhou, Guangdong, China
- Haikou, Hainan, China
- Zhengzhou, Henan, China
- Jining, Shandong, China
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Guangzhou, Guangdong, China; Haikou, Hainan, China; Zhengzhou, Henan, China; Jining, Shandong, China and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.