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

NCT02816333 | Withdrawn

• 1 other identifier: 1-2016-0003
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type B Aortic Dissection

Outcome Measures

Primary Outcomes (1)

• Major adverse event

  A composite of all-cause death, re-intervention, and aortic dilation \> 5 mm in maximal aortic diameter

  12 months

Secondary Outcomes (2)

• Aortic remodeling

  12 months

• Aorta-related complications

  12 months

Study Arms (1)

Type B aortic dissection

Patients with Type B aortic dissection requiring TEVAR

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Type B aortic dissection requiring thoracic endovascular aortic repair

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: June 28, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: June 21, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share