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

January 13, 2015 updated by: Jong-Min Song, Asan Medical Center

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Aortic aneurysm and death
Time Frame: 4 years
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Events and complications
Time Frame: 4 years
paraplegia cerebrovascular accident aorta surgery
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

May 13, 2011

First Submitted That Met QC Criteria

May 13, 2011

First Posted (Estimate)

May 16, 2011

Study Record Updates

Last Update Posted (Estimate)

January 14, 2015

Last Update Submitted That Met QC Criteria

January 13, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADdistal_graft

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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