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Clinical Study for Evaluating the Safety and Efficacy of Total Endovascular Aortic Arch Repair

NCT03347812 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2017-12-27

No results posted yet for this study

Summary

Aortic disease is a kind of cardiovascular diseases with very high mortality rate and high risk of surgical treatment. At present, the surgical and endovascular treatment for diseases in the ascending aorta, descending aorta and abdominal aorta are becoming more and more mature. However, due to the complexity of the aortic arch in anatomy, function and pathological changes, the optimal treatment strategy for diseases in the aortic arch has been controversial constantly.

This research is a multi-center(four centers), prospective, controlled, large-scale (about 400 subjects) clinical study, using traditional thoracic surgery of aortic arch disease as a control to verify that new techniques for endovascular treatment is not inferior to traditional thoracic surgery in terms of efficiency and safety.

Further more, the investigators plan to explore the indications of the application of these new techniques, develop a better diagnosis and treatment program, reduce the risk of such surgical treatment and the incidence of complications, improve clinical efficacy and the overall quality of the disease.

Conditions

  • Aortic Dissection
  • Aortic Arch Aneurysm
  • Ulcer
  • Pseudoaneurysm

Interventions

PROCEDURE

Endovascular Aortic Repair

Without surgery to expose the lesion directly, minimal invasive treatment for the aortic arch lesion under the guidance of imaging equipment is performed through the blood vessel with a tiny wound of a few centimeters, in our research, including chimney, branch stent-grafts and fenestration techniques.

PROCEDURE

Total Arch Replacement

A kind of open surgery is performed for the replacement of total aortic arch.

Sponsors & Collaborators

  • Peking University People's Hospital

    collaborator OTHER

  • China-Japan Friendship Hospital

    collaborator OTHER

  • Beijing Hospital

    collaborator OTHER_GOV

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    lead OTHER

Principal Investigators

  • Chang Shu, Director · Chinese Academy of Medical Sciences, Fuwai Hospital

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-22
Primary Completion
2020-03-31
Completion
2020-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03347812 on ClinicalTrials.gov