G-Branch thoracoabdominal stent graft for thoracoabdominal aortic aneurysm repair

Exploratory Study of Thoracoabdominal Artery Stent Graft System in the Treatment of Thoracoabdominal Aortic Aneurysms

This study will test a new G-Branch thoracoabdominal stent graft to treat adults with thoracoabdominal aortic aneurysms using a total endovascular approach.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 11 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Hamburg)
• Trial ID: NCT06710938 on ClinicalTrials.gov

What this trial studies

This single-center, prospective, single-arm, open-label exploratory study will try the G-Branch thoracoabdominal aortic stent graft system (with peripheral and aortic extension stents) for total endovascular repair of thoracoabdominal aortic aneurysms. Eligible adults who meet size, growth, symptom, and anatomic landing-zone criteria will undergo the procedure and receive scheduled imaging and clinical follow-up. Investigators will collect feasibility and safety outcomes including procedural success, perioperative complications such as respiratory or renal failure, branch patency, and short-term imaging results. As an exploratory single-arm study, results will be interpreted against historical outcomes rather than a randomized control group.

Who should consider this trial

Good fit: Adults age 18–80 with thoracoabdominal aortic aneurysms who meet the trial's size/growth/symptom criteria and have aortic anatomy compatible with the device landing-zone dimensions are ideal candidates.

Not a fit: Patients whose aneurysm anatomy falls outside the device's landing-zone size limits, who require open or hybrid repair, or who have contraindications to endovascular procedures are unlikely to benefit.

Why it matters

Potential benefit: If successful, the device could offer a less invasive total endovascular option that avoids thoracotomy and may reduce early mortality and major organ complications compared with open repair.

How similar studies have performed: Branched and fenestrated endovascular grafts for thoracoabdominal aneurysms have shown encouraging short- and mid-term results in other series, but device-specific prospective feasibility data for the G-Branch remain limited.

Eligibility criteria

Inclusion Criteria:

1. Age: 18 to 80 years old;
2. Patients diagnosed with a Thoracoabdominal aortic aneurysm (based on the modified Crawford classification and European Society for Vascular Surgery (ESVS) 2019 Clinical Practice Guidelines on the Management of Abdominal Aorto-iliac Artery Aneurysms), and should meet at least ONE of the following conditions:

   1. Maximum diameter of TAAA is \>50 mm;
   2. TAAA diameter increases by more than 5 mm in the past 6 months or by more than 10 mm in the past 1 year;
   3. Definite symptoms associated with TAAA, such as abdominal pain and back pain.
3. Anatomical Criteria

   1. Proximal landing zone (aorta or implanted graft): the diameter ranges from 17 to 36 mm, and length should be ≥25 mm;
   2. Distal landing zone (aorta or implanted graft): If distal landing zone is in iliac artery, distal landing zone diameter ranges from 7 to 25 mm, and length should be ≥15 mm; If the distal landing zone is in the abdominal aorta, distal landing zone diameter ranges from 12 to 36 mm, and length should be ≥20 mm.
   3. Visceral branch landing zone: the diameter ranges from 6 to 13 mm, and the length should be ≥15 mm;
   4. Renal artery landing zone: the diameter ranges from 4.5 to 9 mm, and the length should be ≥15 mm;
   5. Appropriate iliac, femoral, and upper limb arterial access.
4. Patients who understand the purpose of the study, volunteer to participate and sign the informed consent form, and are willing to complete follow-up as required by the protocol;
5. Patients do not want to or cannot wait for the approved alternative

Exclusion Criteria:

Exclusion Criteria (not eligible if any of the criteria is met):

1. Patients with ruptured thoracoabdominal aortic aneurysms in unstable hemodynamic condition;
2. Patients with thoracoabdominal aortic dissection;
3. Patients with infected or mycotic thoracoabdominal aortic aneurysms;
4. Patients with systemic or local infections that may increase the risk of endovascular graft infection;
5. Patients with occluded superior mesenteric artery, celiac trunk artery, or renal artery;
6. Patients requiring simultaneous coverage or embolization of bilateral internal iliac arteries;
7. Patients with severe stenosis, calcification or mural thrombus at stent-graft landing zone, and this situation leads to difficulty in adhering the covered stent or affecting the patency of the stent;
8. Patients with a history of acute coronary syndrome within the recent 6 months; Acute coronary syndrome refers to acute cardiac ischemic syndrome caused by rupture or erosion of unstable atherosclerotic plaques in the coronary artery and fresh thrombosis, including ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI) and unstable angina pectoris.
9. Patients with transient ischemic attack (TIA) or ischemic/hemorrhagic stroke within the recent 3 months;
10. Patients with abnormal liver and kidney function before operation \[alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 times the upper limit of normal value; Serum creatinine (Cr) \>150umol/L\];
11. Patients with severe pulmonary insufficiency who cannot tolerate general anesthesia;

Where this trial is running

Hamburg

• Asklepios Klinik Nord Heidberg — Hamburg, Germany (Recruiting)

Study contacts

• Study coordinator: Rae Gong

Conditions Thoracoabdominal Aortic Aneurysms; G-branch Stent Graft; Lifetech Scientific; Thoracoabdominal Artery Stent Graft System