Korean Registry of Thoracic Endovascular Aortic Repair Ti... | NCT02816333

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

NCT02816333

Sponsor

Yonsei University

Status

Withdrawn

Last Update Posted

Jun 21, 2018Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Type B Aortic Dissection

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to the withdrawal of Gore Korea Co.Ltd., manufacturer of medical device, it is impossible to supply the medical device(C-TAG).

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Jun 2020Estimated

Completion Date

Jun 2020Estimated

First Submitted Date

Jun 23, 2016

First Submission Date that Met QC Criteria

Jun 23, 2016

First Posted Date

Jun 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2018

Last Update Posted Date

Jun 21, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
Type B aortic dissection		Patients with Type B aortic dissection requiring TEVAR

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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,
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.
Declaration of voluntary participation in the study with signed informed consent form.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with Type B aortic dissection requiring thoracic endovascular aortic repair

Sampling Method

Non-Probability Sample