Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06915545

Study on the Aortic Arch Single Branch Stent Graft System

Led by Lifetech Scientific (Shenzhen) Co., Ltd. · Updated on 2025-06-11

135

Participants Needed

1

Research Sites

321 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The objective of the study is to evaluate the Safety and Efficacy of Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch

CONDITIONS

Official Title

Study on the Aortic Arch Single Branch Stent Graft System

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 80 years, any gender
  • Diagnosed with Stanford Type B aortic dissection needing left subclavian artery revascularization
  • Proximal aortic landing zone diameter between 20 and 42 mm
  • Proximal aortic landing zone length of at least 15 mm
  • Distance between left common carotid artery and left subclavian artery at least 5 mm
  • Left subclavian artery landing zone length of at least 25 mm and diameter between 5 and 15 mm
  • Suitable access to femoral, iliac, and upper limb arteries
  • Willingness to participate and complete follow-up visits as required
Not Eligible

You will not qualify if you...

  • Previous endovascular treatment or surgical repair involving the aortic arch affecting stent evaluation
  • Severe stenosis, calcification, or thrombus in stent anchoring area preventing proper stent adherence
  • Infectious aortic diseases, giant cell arteritis, Marfan syndrome, or other hereditary connective tissue diseases
  • Systemic or local infections increasing risk of graft infection
  • Abdominal aortic surgery or endovascular intervention within past 3 months
  • Stroke (excluding TIA) or myocardial infarction within past 3 months
  • Known allergy to contrast agents or stent and delivery device materials
  • Contraindications to anticoagulant or antiplatelet drugs
  • Intolerance to general anesthesia
  • Severe liver, kidney, or cardiac dysfunction before operation (specific lab value thresholds)
  • Expected lifespan under 1 year
  • Female patients planning pregnancy, pregnant, or breastfeeding
  • Judged unsuitable for endovascular treatment by researcher
  • Participation in other clinical studies without withdrawal within 3 months before screening

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

Second Xiangya Hospital of Central South University

Changsha, China

Actively Recruiting

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Research Team

C

chang shu, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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