Thoracoabdominal Artery Stent Graft System Exploratory Study

NCT06710938 | Recruiting

• 1 other identifier: LT/TS-TAAA-EU-01
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed as a single-center, prospective, single-arm, open-label, exploratory study. The objective is to evaluate the feasibility of Thoracoabdominal Artery Stent Graft System for endovascular treatment of Thoracoabdominal aortic aneurysms (TAAA).

Conditions

Thoracoabdominal Aortic Aneurysms

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Treatment success rate

  Treatment success is a composite index that should meet all of the following criteria: * Immediate technical success: refers to successful delivery of the delivery system to the intended location, successful deployment of the stent graft, withdrawal of the delivery system, with no type I/III endoleak) \[Timeframe: intraoperative\], * No TAAA-related secondary intervention (including secondary intervention due to aneurysm rupture, sustained enlargement, stent migration, type I/III endoleak, branch stenosis/occlusion) \[Timeframe: 12-month post operation\].

  Intraoperative and 12-month post operation

• Incidence of major adverse events (MAEs): 30-day post operation

  MAEs are defined as all-cause death, hepatic failure, bowel necrosis, renal failure, stroke, permanent paraplegia, myocardial infarction, and respiratory failure.

  30-day post operation

Secondary Outcomes (10)

• Incidence of perioperative delivery system-related complications

  intraoperative and within 30-day post operation

• All-cause mortality

  6-month, 12-month, and 2- to 5-year post operation

• TAAA-related mortality

  6-month, 12-month, and 2- to 5-year post operation

• Incidence of serious adverse events (SAEs)

  6-month, 12-month, and 2- to 5-year post operation

• Incidence of device-related adverse events

  6-month, 12-month, and 2- to 5-year post operation

Study Arms (1)

Endovascular therapy used as treatment of TAAA

EXPERIMENTAL

Traditional methods of treatment of TAAA include open surgery and hybrid surgery. Open surgery requires Thoracoabdominal incision which will result in a huge wound and the reconstruction of the visceral artery is also complicated. endovascular therapy has been developed for many years and has demonstrated significant advantages, such as small wounds, and fewer complications. Now Endovascular therapy is gradually used in the treatment of TAAA as well. Compared with traditional open surgery and hybrid surgery, the risk-benefit ratio of endovascular therapy is much better. When the risk-benefit gap between the investigational device and existing treatments is so wide that a control group is ethically unfeasible. So a single-arm exploratory study is adopted.

Device: The system includes the G-Branch™ thoracoabdominal aortic stent graft system, the peripheral vascular stent graft system, and the aortic extension stent graft system

Interventions

The system includes the G-Branch™ thoracoabdominal aortic stent graft system, the peripheral vascular stent graft system, and the aortic extension stent graft system DEVICE

The thoracoabdominal artery stent graft system is a mixed branch design with two inner branches for the visceral arteries and two outer branches for the bilateral renal arteries.

Endovascular therapy used as treatment of TAAA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 to 80 years old;
• 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:
• Maximum diameter of TAAA is \>50 mm;
• TAAA diameter increases by more than 5 mm in the past 6 months or by more than 10 mm in the past 1 year;
• Definite symptoms associated with TAAA, such as abdominal pain and back pain.
• Anatomical Criteria
• Proximal landing zone (aorta or implanted graft): the diameter ranges from 17 to 36 mm, and length should be ≥25 mm;
• 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.
• Visceral branch landing zone: the diameter ranges from 6 to 13 mm, and the length should be ≥15 mm;
• Renal artery landing zone: the diameter ranges from 4.5 to 9 mm, and the length should be ≥15 mm;
• Appropriate iliac, femoral, and upper limb arterial access.
• 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;
• Patients do not want to or cannot wait for the approved alternative

You may not qualify if:

• Patients with ruptured thoracoabdominal aortic aneurysms in unstable hemodynamic condition;
• Patients with thoracoabdominal aortic dissection;
• Patients with infected or mycotic thoracoabdominal aortic aneurysms;
• Patients with systemic or local infections that may increase the risk of endovascular graft infection;
• Patients with occluded superior mesenteric artery, celiac trunk artery, or renal artery;
• Patients requiring simultaneous coverage or embolization of bilateral internal iliac arteries;
• 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;
• 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.
• Patients with transient ischemic attack (TIA) or ischemic/hemorrhagic stroke within the recent 3 months;
• Patients with abnormal liver and kidney function before operation \[alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 times the upper limit of normal value; Serum creatinine (Cr) \>150umol/L\];
• Patients with severe pulmonary insufficiency who cannot tolerate general anesthesia;

Sponsors & Collaborators

• Lifetech Scientific (Shenzhen) Co., Ltd.: lead

Study Sites (1)

Asklepios Klinik Nord Heidberg

Hamburg, Germany

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Abdominal; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Central Study Contacts

Rae Gong

CONTACT

+86 18820162460; gongrui@lifetechmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Thoracoabdominal Artery Stent Graft System. The system includes the G-Branch™ thoracoabdominal aortic stent graft system, the peripheral vascular stent graft system, and the aortic extension stent graft system.

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 29, 2024
• Study Start: July 24, 2025
• Primary Completion (Estimated): February 1, 2031
• Study Completion (Estimated): February 1, 2031
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

DE (1)