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

This study has been terminated.
(Not enough participants enrolled)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01354119
First Posted: May 16, 2011
Last Update Posted: January 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jong-Min Song, Asan Medical Center
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Jong-Min Song, Asan Medical Center:

Primary Outcome Measures:
  • Aortic aneurysm and death [ Time Frame: 4 years ]

Secondary Outcome Measures:
  • Events and complications [ Time Frame: 4 years ]
    paraplegia cerebrovascular accident aorta surgery


Enrollment: 7
Study Start Date: January 2011
Study Completion Date: December 2014
Primary Completion Date: December 2014 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354119


Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
  More Information

Responsible Party: Jong-Min Song, Associate professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01354119     History of Changes
Other Study ID Numbers: ADdistal_graft
First Submitted: May 13, 2011
First Posted: May 16, 2011
Last Update Posted: January 14, 2015
Last Verified: January 2015

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