Korean Registry of Thoracic Endovascular Aortic Repair Timing for Type B Aortic Dissection (K-TEAM Study): A Prospective Multicenter Registry

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02816333

Enrollment

Registered

2016-06-28

Start date

2016-06-30

Completion date

2020-06-30

Last updated

2018-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type B Aortic Dissection

Brief 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. CT will be performed at 12 months.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 79 Years

Healthy volunteers

Inclusion criteria

1. 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 2. Age 19-80 years. 3. Aorta anatomy appropriate for stent graft therapy, 1. Proximal landing zone (diameters between 23 and 42 mm) is not aneurysmal, dissected or significantly thrombosed. 2. 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. 4. Declaration of voluntary participation in the study with signed informed consent form.

Exclusion criteria

1. Endorgan ischemia or evidence of malperfusion due to aortic dissection 2. Aortic rupture or impeding rupture due to aortic dissection 3. Renal dysfunction with serum Cr level \>2.0 mg/dL 4. Marfan syndrome, Loeys-Diets, Ehlers-Danlos syndrome, or other connective tissue diseases 5. Uncontrolled active infection or active vasculitis. 6. Recent myocardial infarction or cerebrovascular accident within 4 weeks prior to study enrollment. 7. Previous thoracic aorta surgery or stent-graft implantation 8. Planned concomitant surgical procedures (other than left subclavian artery transposition or bypass) or major surgery within 30 days of study enrolment. 9. Women with positive pregnancy test or at child bearing age 10. Life expectancy \<1 year due to comorbidity

Design outcomes

Primary

Measure	Time frame	Description
Major adverse event	12 months	A composite of all-cause death, re-intervention, and aortic dilation \> 5 mm in maximal aortic diameter

Secondary

Measure	Time frame	Description
Aortic remodeling	12 months	Change in maximal aorta, true lumen, and false lumen dimensions
Aorta-related complications	12 months	composite events of aortic rupture, stroke, spinal chord ischemia, retrograde dissection, endoleaks, aortic dilation \> 5mm in diameter

Outcome results