Type B Aortic DissectionNCT02816333
Korean Registry of Thoracic Endovascular Aortic Repair Timing for Type B Aortic Dissection (K-TEAM Study): A Prospective Multicenter Registry
An observational study of Type B Aortic Dissection, run by Yonsei University.
Trial summary
Prospective, single-arm, multi-center registry study A total of 50 subjects with Type B aortic dissection who meet all inclusion and exclusion criteria will be included. Patients will be treated with TEVAR using conformable TAG endograft (Gore). Patients will be followed clinically for 12 months after the procedure. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Type B Aortic Dissection
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2020
- Phase
- Observational
- 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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Type B aortic dissection requiring thoracic endovascular aortic repair
Who may be able to join
- a) In case of acute Type B dissection (14 days from first dissection)
- Maximum aortic diameter >40 mm or
- Increase in aortic diameter >2 mm from baseline b) In case of subacute (15~90 days) or chronic (90 days ~ 1 year) Type B
- Maximum aortic diameter >55 mm or
- Increase in aortic diameter >4 mm from baseline
- Age 19-80 years.
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- Aorta anatomy appropriate for stent graft therapy,
- Proximal landing zone (diameters between 23 and 42 mm) is not aneurysmal, dissected or significantly thrombosed.
- Proximal landing zone length >20 mm (length from the left subclavian artery origin to the primary intima tear or length from the left common carotid artery origin to the primary intima tear when the left subclavian artery is embolized and possibly revascularized), as measured from the outer curve of the aorta.
- Declaration of voluntary participation in the study with signed informed consent form.
Who cannot join
- Endorgan ischemia or evidence of malperfusion due to aortic dissection
- Aortic rupture or impeding rupture due to aortic dissection
- Renal dysfunction with serum Cr level >2.0 mg/dL
- Marfan syndrome, Loeys-Diets, Ehlers-Danlos syndrome, or other connective tissue diseases
- Uncontrolled active infection or active vasculitis.
- Recent myocardial infarction or cerebrovascular accident within 4 weeks prior to study enrollment.
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- Previous thoracic aorta surgery or stent-graft implantation
- Planned concomitant surgical procedures (other than left subclavian artery transposition or bypass) or major surgery within 30 days of study enrolment.
- Women with positive pregnancy test or at child bearing age
- Life expectancy <1 year due to comorbidity
About this study
Prospective, single-arm, multi-center registry study A total of 50 subjects with Type B aortic dissection who meet all inclusion and exclusion criteria will be included.
Patients will be treated with TEVAR using conformable TAG endograft (Gore). Patients will be followed clinically for 12 months after the procedure. CT will be performed at 12 months.
- Conditions
- Type B Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Type B aortic dissection | Patients with Type B aortic dissection requiring TEVAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse event
A composite of all-cause death, re-intervention, and aortic dilation > 5 mm in maximal aortic diameter
Measured: 12 months
Secondary outcomes (2)
Aortic remodeling
Change in maximal aorta, true lumen, and false lumen dimensions
Measured: 12 months
Aorta-related complications
composite events of aortic rupture, stroke, spinal chord ischemia, retrograde dissection, endoleaks, aortic dilation > 5mm in diameter
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Why it stopped: Due to the withdrawal of Gore Korea Co.Ltd., manufacturer of medical device, it is impossible to supply the medical device(C-TAG).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type B Aortic DissectionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816333
- Sponsor's protocol ID
- 1-2016-0003
- Status last verified
- Jun 2018
- First submitted
- 23 Jun 2016
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: no plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Korean Registry of Thoracic Endovascular Aortic Repair Timing for Type B Aortic Dissection (K-TEAM Study): A Prospective Multicenter Registry
- ClinicalTrials.gov ID
- NCT02816333
- Acronym / sponsor ID
- 1-2016-0003
- Conditions
- Type B Aortic Dissection
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Due to the withdrawal of Gore Korea Co.Ltd., manufacturer of medical device, it is impossible to supply the medical device(C-TAG).
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 28 Jun 2016 (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.
Prospective, single-arm, multi-center registry study A total of 50 subjects with Type B aortic dissection who meet all inclusion and exclusion criteria will be included.
Patients will be treated with TEVAR using conformable TAG endograft (Gore). Patients will be followed clinically for 12 months after the procedure. CT will be performed at 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type B aortic dissection | – | –Patients with Type B aortic dissection requiring TEVAR |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Type B aortic dissection requiring thoracic endovascular aortic repair
Key inclusion criteria (10 listed)
- a) In case of acute Type B dissection (14 days from first dissection)
- Age 19-80 years.
- Aorta anatomy appropriate for stent graft therapy,
- Declaration of voluntary participation in the study with signed informed consent form.
Key exclusion criteria (10 listed)
- Endorgan ischemia or evidence of malperfusion due to aortic dissection
- Aortic rupture or impeding rupture due to aortic dissection
- Renal dysfunction with serum Cr level >2.0 mg/dL
- Marfan syndrome, Loeys-Diets, Ehlers-Danlos syndrome, or other connective tissue diseases
- Uncontrolled active infection or active vasculitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major adverse event
Time frame: 12 months
A composite of all-cause death, re-intervention, and aortic dilation > 5 mm in maximal aortic diameter
2 secondary outcomes
Aortic remodeling
Time frame: 12 months
Aorta-related complications
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
- Individual participant dataSharing planned: No. no plan to share data
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Type B Aortic Dissection, run by Yonsei University.
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 10 inclusion and 10 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: withdrawn, as of the sponsor's last update on 21 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Major adverse event (time frame: 12 months). 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 21 Jun 2018.