Hybrid Treatment of Type B Aortic Dissection

September 12, 2017 updated by: Dmitry Sirota, Meshalkin Research Institute of Pathology of Circulation

Superiority Trial of Type b Aortic Dissection Treatment Combined With Implantation of Bare Metal Stent in Abdominal Part of Aorta Versus Conventional Type b Treatment

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Main hypothesis of this study is that thoracoabdominal aortic repair combined with bare metal stent implantation is better permanent neurological deficits, perioperative bleeding, malperfusion of viscera over conventional thoracoabdominal aortic repair.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hybrid TAAD repair
The group includes patients who underwent open thoracoabdominal aortic repair + abdominal stenting.
Procedure: Open thoracoabdominal aortic repair + abdominal stenting
Thoracoabdominal aortic dissection (TAAD) repair + bare aortic stent (Djumbodis) implantation
Other Names:
  • Hybrid thoracoabdominal aortic repair
Active Comparator: Conventional TAAD repair
The group includes patients who underwent classic thoracoabdominal aortic repair with dacron prosthesis.
Procedure: Classic thoracoabdominal aortic repair
Thoracoabdominal aortic dissection (TAAD) repair
Other Names:
  • Conventional TAAD repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Permanent neurological events
Time Frame: 30 days
Quantity of permanent neurological events such as stroke and paraplegia by 30th day after procedure.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative bleeding
Time Frame: 5 days after procedure
Volume of perioperative and postoperative bleeding in ICU
5 days after procedure
Mortality
Time Frame: 6 months
Postoperative mortality will be measured during 6 months after procedure
6 months
Visceral malperfusion
Time Frame: 6 months
Clinical evidences of visceral malperfusion (acute or achronic abdomen ischemia) during 6 months after procedure (Yes or No)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Investigators

  • Study Chair: Alexander M. Chernyavskiy, MD PhD, Academician Ye. Meshalkin Novosibirsk Research Institute of Circulation Pathology Ministry of Health care of Russian Federation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

January 27, 2016

First Submitted That Met QC Criteria

April 1, 2016

First Posted (Estimate)

April 4, 2016

Study Record Updates

Last Update Posted (Actual)

September 13, 2017

Last Update Submitted That Met QC Criteria

September 12, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAAD+bare stent

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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