NCT01354119

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 16, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 14, 2015

Status Verified

January 1, 2015

Enrollment Period

3.9 years

First QC Date

May 13, 2011

Last Update Submit

January 13, 2015

Conditions

Aortic DissectionAortic AneurysmStent-graft

Outcome Measures

Primary Outcomes (1)

  • Aortic aneurysm and death

    4 years

Secondary Outcomes (1)

  • Events and complications

    4 years

Study Arms (2)

Early intervention

ACTIVE COMPARATOR

Early intervention: stent-graft just after acute phase

Procedure: Aortic stent-graft

Conservative

NO INTERVENTION

Conservative: medial follow-up without early intervention

Interventions

Aortic stent-graftPROCEDURE

Early intervention with aortic stent-graft

Early intervention

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Aortic DissectionAortic Aneurysm

Condition Hierarchy (Ancestors)

Dissection, Blood VesselAneurysmVascular DiseasesCardiovascular DiseasesAcute Aortic SyndromeAortic Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

May 13, 2011

First Posted

May 16, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 14, 2015

Record last verified: 2015-01

Locations

KR(1)