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Long-term Benefit of Aortic Stent-graft in Patients With Distal Aortic Dissection

This study is currently recruiting participants.
Verified December 2011 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
Jong-Min Song, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01354119
First received: May 13, 2011
Last updated: December 29, 2011
Last verified: December 2011
History of Changes
  Purpose

Background: Aortic stent-graft is useful to occlude intimal tear and prevent further dilatation of the false lumen in patients with aortic dissection. The long-term benefit of aortic stent-graft in patients with uncomplicated distal aortic dissection has not been well demonstrated, especially in patients at high risk of aneurysmal change and death.

Purpose: The purpose of the study is to evaluate long-term clinical benefit of stent-graft insertion performed just after the acute phase into the descending thoracic aorta in patients with distal aortic dissection and at high risk of aneurysmal change of the dissected aorta.


Condition Intervention Phase
Aortic Dissection
Aortic Aneurysm
Stent-graft
 Procedure: Aortic stent-graft
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Aortic aneurysm and death [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Events and complications [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    paraplegia cerebrovascular accident aorta surgery


Estimated Enrollment: 120
Study Start Date: January 2011
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Early intervention
Early intervention: stent-graft just after acute phase
 Procedure: Aortic stent-graft
Early intervention with aortic stent-graft
No Intervention: Conservative
Conservative: medial follow-up without early intervention

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Uncomplicated distal aortic dissection
  • Initial false lumen diameter >= 22 mm

Exclusion Criteria:

  • Old age (> 75 years old)
  • Other comorbidity or malignancy with life expectancy < 5 years
  • Complicated dissection requiring aortic surgery or intervention
  • Sudden death in acute phase
  • Marfan syndrome
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354119

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Jong-Min Song, MD, PhD     +82-2-3010-3168     jmsong@amc.seoul.kr    
Principal Investigator: Jong-Min Song, MD, PhD            
Sponsors and Collaborators
Asan Medical Center
  More Information

No publications provided

Responsible Party: Jong-Min Song, Associate professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01354119     History of Changes
Other Study ID Numbers: ADdistal_graft
Study First Received: May 13, 2011
Last Updated: December 29, 2011
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on May 22, 2013