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

NCT ID: NCT01354119

Last Updated: 2015-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Aortic Dissection Aortic Aneurysm Stent-graft

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early intervention

Early intervention: stent-graft just after acute phase

Group Type ACTIVE_COMPARATOR

Aortic stent-graft

Intervention Type PROCEDURE

Early intervention with aortic stent-graft

Conservative

Conservative: medial follow-up without early intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Aortic stent-graft

Early intervention with aortic stent-graft

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jong-Min Song

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Asan Medical Center

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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ADdistal_graft

Identifier Type: -

Identifier Source: org_study_id

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