Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06710938

Thoracoabdominal Artery Stent Graft System Exploratory Study

Led by Lifetech Scientific (Shenzhen) Co., Ltd. · Updated on 2025-08-28

11

Participants Needed

1

Research Sites

288 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Thoracoabdominal Artery Stent Graft System Exploratory Study

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 80 years
  • Diagnosed with Thoracoabdominal aortic aneurysm based on specific clinical guidelines
  • Have at least one of these: TAAA maximum diameter over 50 mm, diameter growth over 5 mm in 6 months or 10 mm in 1 year, or symptoms like abdominal or back pain
  • Proximal aorta landing zone diameter 17 to 36 mm, length at least 25 mm
  • Distal landing zone diameter and length meet specified size criteria for iliac artery or abdominal aorta
  • Visceral branch landing zone diameter 6 to 13 mm and length at least 15 mm
  • Renal artery landing zone diameter 4.5 to 9 mm and length at least 15 mm
  • Suitable arterial access through iliac, femoral, and upper limb arteries
  • Able to understand study purpose, consent to participate, and complete follow-up
  • Not willing or able to wait for approved alternative treatments
Not Eligible

You will not qualify if you...

  • Unstable condition due to ruptured thoracoabdominal aortic aneurysm
  • Thoracoabdominal aortic dissection
  • Infected or mycotic thoracoabdominal aortic aneurysms
  • Systemic or local infections increasing risk of graft infection
  • Occluded superior mesenteric, celiac trunk, or renal artery
  • Need for simultaneous coverage or embolization of both internal iliac arteries
  • Severe stenosis, calcification, or thrombus at landing zones affecting stent adherence or patency
  • History of acute coronary syndrome within 6 months
  • Transient ischemic attack or stroke within 3 months
  • Abnormal liver or kidney function before operation (high ALT, AST, or creatinine)
  • Severe pulmonary insufficiency preventing tolerance of general anesthesia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Asklepios Klinik Nord Heidberg

Hamburg, Germany

Actively Recruiting

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Research Team

R

Rae Gong

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

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