Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT05054985

Safety and Efficacy of a Multi-branched Thoracoabdominal Stent Graft System for Thoracoabdominal Aortic Aneurysm.

Led by Lifetech Scientific (Shenzhen) Co., Ltd. · Updated on 2025-06-22

73

Participants Needed

1

Research Sites

372 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Evaluation of the safety and efficacy of a multi-branched thoracoabdominal stent graft system for thoracoabdominal aortic aneurysm.

CONDITIONS

Official Title

Safety and Efficacy of a Multi-branched Thoracoabdominal Stent Graft System for Thoracoabdominal Aortic Aneurysm.

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 guidelines
  • Aneurysm maximum diameter greater than 50mm or increased size by more than 5mm in 6 months or 10mm in 1 year
  • Proximal anchoring region diameter 17-36 mm and length at least 25 mm
  • Distal anchoring region diameter 7-25 mm (iliac artery) or 12-36 mm (abdominal aorta) with minimum length
  • Visceral branch vessel anchoring diameter 6-13 mm and length at least 15 mm
  • Renal artery anchoring area diameter 4.5-9 mm and length at least 15 mm
  • Suitable iliac, femoral, and upper limb artery access
  • Able to understand trial purpose, consent voluntarily, and complete follow-up
Not Eligible

You will not qualify if you...

  • Hemodynamically unstable with ruptured thoracoabdominal aortic aneurysms
  • Thoracoabdominal aortic dissection
  • Mycotic or infectious thoracoabdominal aortic aneurysm
  • Systemic or local infection increasing graft infection risk
  • Occlusion of superior mesenteric, celiac, or renal artery
  • Need for simultaneous coverage and embolization of both internal iliac arteries
  • Severe stenosis, calcification, or thrombus in stent anchoring area
  • Acute coronary syndrome within 6 months
  • Transient ischemic attack or stroke within 3 months
  • Significant liver or kidney function abnormalities
  • Severe lung problems preventing general anesthesia
  • Severe coagulation problems
  • Major surgery or intervention within 30 days before procedure
  • Allergy to contrast agents, anticoagulants, antiplatelet drugs, stents, or related materials
  • Connective tissue diseases like lupus, Marfan's, Adam's, or Behcet's disease
  • Takayasu arteritis
  • Serious vital organ dysfunction or other serious diseases
  • Pregnancy, planning pregnancy, or breastfeeding
  • Participation in other clinical trials without withdrawal in first 3 months
  • Life expectancy less than 1 year
  • Investigator judgment of ineligibility for endotherapy

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

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

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Research Team

W

Wei Guo, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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