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

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 Overview

• Status: Withdrawn
• Conditions: Type B Aortic Dissection

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Type B aortic dissection requiring thoracic endovascular aortic repair

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Type B aortic dissection; Patients with Type B aortic dissection requiring TEVAR

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: June 23, 2016
• First Submitted That Met QC Criteria: June 23, 2016
• First Posted (Estimate): June 28, 2016

Study Record Updates

• Last Update Posted (Actual): June 21, 2018
• Last Update Submitted That Met QC Criteria: June 19, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting
• Other Study ID Numbers: 1-2016-0003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no plan to share data