NCT02726841

Brief Summary

Authors hypothesize that thoracoabdominal aortic repair combined with bare metal stent implantation is superior over standard thoracoabdominal aortic repair.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 4, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

September 13, 2017

Status Verified

September 1, 2017

Enrollment Period

6 years

First QC Date

January 27, 2016

Last Update Submit

September 12, 2017

Conditions

Aortic Dissection Type B

Keywords

Thoracic aortaAbdominal aortaStents

Outcome Measures

Primary Outcomes (1)

  • Permanent neurological events

    Quantity of permanent neurological events such as stroke and paraplegia by 30th day after procedure.

    30 days

Secondary Outcomes (3)

  • Perioperative bleeding

    5 days after procedure

  • Mortality

    6 months

  • Visceral malperfusion

    6 months

Study Arms (2)

Hybrid TAAD repair

EXPERIMENTAL

The group includes patients who underwent open thoracoabdominal aortic repair + abdominal stenting.

Procedure: Open thoracoabdominal aortic repair + abdominal stenting

Conventional TAAD repair

ACTIVE COMPARATOR

The group includes patients who underwent classic thoracoabdominal aortic repair with dacron prosthesis.

Procedure: Classic thoracoabdominal aortic repair

Interventions

Open thoracoabdominal aortic repair + abdominal stentingPROCEDURE

Thoracoabdominal aortic dissection (TAAD) repair + bare aortic stent (Djumbodis) implantation

Also known as: Hybrid thoracoabdominal aortic repair
Hybrid TAAD repair
Classic thoracoabdominal aortic repairPROCEDURE

Thoracoabdominal aortic dissection (TAAD) repair

Also known as: Conventional TAAD repair
Conventional TAAD repair

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with chronic aortic dissection type B
  • Aortic size in descending thoracoabdominal aorta (TAA) \> 55 mm

You may not qualify if:

  • concomitant cardiac pathology
  • concomitant oncology diseases in the last 5 years
  • acute aortic dissection
  • aortic size in visceral zone \>45 mm
  • connectivity tissue diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Alexander M. Chernyavskiy, MD PhD

    Academician Ye. Meshalkin Novosibirsk Research Institute of Circulation Pathology Ministry of Health care of Russian Federation

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiac surgeon

Study Record Dates

First Submitted

January 27, 2016

First Posted

April 4, 2016

Study Start

January 1, 2013

Primary Completion

January 1, 2019

Study Completion

January 1, 2020

Last Updated

September 13, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share