Actively Recruiting

Phase Not Applicable
Age: 20Years - 65Years
All Genders
NCT06492980

A Triple-branched Stent Graft for Aute Debakey Type I Dissection Surgery

Led by Fujian Medical University · Updated on 2024-07-09

150

Participants Needed

1

Research Sites

102 weeks

Total Duration

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AI-Summary

What this Trial Is About

Prospective, multicenter, randomized controlled clinical trial plan to evaluate the effectiveness and safety of intraoperative stent system in the treatment of acute type I aortic dissection

CONDITIONS

Official Title

A Triple-branched Stent Graft for Aute Debakey Type I Dissection Surgery

Who Can Participate

Age: 20Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with acute type I aortic dissection who need arch repair
  • Aged 20 years and older but not older than 65 years
  • Acute phase with onset within 14 days before surgery
  • Able to understand the purpose of the trial, voluntarily participate, sign informed consent, and willing to accept follow-up
Not Eligible

You will not qualify if you...

  • Anatomical variations such as aortic arch malformation, aortic coarctation, common origin of innominate artery and left common carotid artery, aberrant right subclavian artery, abnormal origin of left conical artery, stenosis or distortion of branch arteries, or mismatch of aortic arch and branch artery diameters with test device
  • Dissection secondary to previous aortic treatment or Marfan syndrome
  • Aortic and branch artery lesions causing severe ischemic complications like myocardial ischemia, stroke, paraplegia, mesenteric artery ischemia, or renal artery dysplasia
  • Severe uncontrolled infectious lesions
  • Need for other concomitant treatments for severe underlying conditions such as hypertension, chronic obstructive pulmonary disease, coronary heart disease, or chronic kidney disease
  • Other life-threatening lesions including advanced malignant tumors with expected survival less than one year
  • Other heart and aorta diseases requiring concurrent surgery or unsuitable for stent treatment such as peripheral vascular disease and blood diseases
  • Participation in other drug or device clinical trials without reaching primary endpoint
  • Pregnancy

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

Department of Cardiovascular Surgery

Fuzhou, Fujian, China, 350001

Actively Recruiting

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Research Team

L

Liang-wan Chen, M.D Ph.D

CONTACT

X

Xiao-fu Dai, M.D Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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A Triple-branched Stent Graft for Aute Debakey Type I Dissection Surgery | DecenTrialz