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

Aortic Aneurysm Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01354119
• Other study ID #: ADdistal_graft
• Status: Terminated
• Phase: Phase 4
• First received: May 13, 2011
• Last updated: January 13, 2015
• Start date: January 2011
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Aortic Aneurysm
• Aortic Dissection
• Stent-graft

Intervention

Procedure:
• Aortic stent-graft
Early intervention with aortic stent-graft

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aortic aneurysm and death		4 years	No
Secondary	Events and complications	paraplegia cerebrovascular accident aorta surgery	4 years	No