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

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ClinicalTrials.gov Identifier: NCT01354119
Recruitment Status : Terminated (Not enough participants enrolled)
First Posted : May 16, 2011
Last Update Posted : January 14, 2015
Sponsor:
Information provided by (Responsible Party):
Jong-Min Song, Asan Medical Center

Brief Summary:

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 or disease Intervention/treatment Phase
Aortic Dissection Aortic Aneurysm Stent-graft Procedure: Aortic stent-graft Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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

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



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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

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

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

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