Aortic DissectionPhase 4NCT01354119
Long-term Benefit of Aortic Stent-graft in Patients With Distal Aortic Dissection
A Phase 4 study testing Aortic stent-graft in people with Aortic Dissection and Aortic Aneurysm, run by Asan Medical Center at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Aortic Dissection, Aortic Aneurysm, Stent-graft
- What is being tested?
- Aortic stent-graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2011to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Uncomplicated distal aortic dissection
- Initial false lumen diameter >= 22 mm
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Aortic Dissection, Aortic Aneurysm, Stent-graft
- Being tested
- Aortic stent-graft
- Medical subject headings
- Aortic Dissection, Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic stent-graftProcedure or surgery
Early intervention with aortic stent-graft
| Study group | Role | What they receive |
|---|---|---|
| Early intervention | Active comparator | Early intervention: stent-graft just after acute phase Receives: Procedure: Aortic stent-graft |
| Conservative | No intervention | Conservative: medial follow-up without early intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic aneurysm and death
Measured: 4 years
Secondary outcomes (1)
Events and complications
paraplegia cerebrovascular accident aorta surgery
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Not enough participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong-Min Song, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354119
- Sponsor's protocol ID
- ADdistal_graft
- Status last verified
- Jan 2015
- First submitted
- 13 May 2011
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Benefit of Aortic Stent-graft in Patients With Distal Aortic Dissection
- ClinicalTrials.gov ID
- NCT01354119
- Acronym / sponsor ID
- ADdistal_graft
- Conditions
- Aortic Dissection, Aortic Aneurysm, Stent-graft
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough participants enrolled
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 16 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early intervention | Active comparator | Procedure: Aortic stent-graftEarly intervention: stent-graft just after acute phase |
| Conservative | No intervention | –Conservative: medial follow-up without early intervention |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Uncomplicated distal aortic dissection
- Initial false lumen diameter >= 22 mm
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aortic stent-graftEarly intervention with aortic stent-graft | Procedure or surgery | Early intervention |
Primary outcome
Aortic aneurysm and death
Time frame: 4 years
1 secondary outcome
Events and complications
Time frame: 4 years
Results and safety
The study was stopped early (reason given: Not enough participants enrolled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
Related trials for Aortic Dissection
Not yet recruitingPhase 2
D2 Gastrectomy With or Without Para-Aortic Lymph Node Dissection After Chemoimmunotherapy for Gastric Cancer
Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Not yet recruitingObservational study
Clinical Health Outcomes Evaluation of Terumo Aortic Hybrid Devices
Aortic Aneurysm and Dissection
Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
RecruitingObservational study
Metabolic Phenotyping in vEDS
Vascular Ehlers-Danlos Syndrome, Vascular Ehlers Danlos Syndrome
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aortic stent-graft in people with Aortic Dissection and Aortic Aneurysm, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Not enough participants enrolled). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aortic aneurysm and death (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2015.