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

Type B Aortic Dissection Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02816333
• Other study ID #: 1-2016-0003
• Status: Withdrawn
• Start date: June 2016
• Est. completion date: June 2020

Study information

• Verified date: June 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. CT will be performed at 12 months.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Type B Aortic Dissection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse event	A composite of all-cause death, re-intervention, and aortic dilation > 5 mm in maximal aortic diameter	12 months
Secondary	Aortic remodeling	Change in maximal aorta, true lumen, and false lumen dimensions	12 months
Secondary	Aorta-related complications	composite events of aortic rupture, stroke, spinal chord ischemia, retrograde dissection, endoleaks, aortic dilation > 5mm in diameter	12 months