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Hybrid Treatment of Type B Aortic Dissection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02726841
Recruitment Status : Unknown
Verified September 2017 by Dmitry Sirota, Meshalkin Research Institute of Pathology of Circulation.
Recruitment status was:  Enrolling by invitation
First Posted : April 4, 2016
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Dmitry Sirota, Meshalkin Research Institute of Pathology of Circulation

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

Condition or disease Intervention/treatment Phase
Aortic Dissection Type B Procedure: Open thoracoabdominal aortic repair + abdominal stenting Procedure: Classic thoracoabdominal aortic repair Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2013
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2020

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 Name: 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 Name: Conventional TAAD repair




Primary Outcome Measures :
  1. Permanent neurological events [ Time Frame: 30 days ]
    Quantity of permanent neurological events such as stroke and paraplegia by 30th day after procedure.


Secondary Outcome Measures :
  1. Perioperative bleeding [ Time Frame: 5 days after procedure ]
    Volume of perioperative and postoperative bleeding in ICU

  2. Mortality [ Time Frame: 6 months ]
    Postoperative mortality will be measured during 6 months after procedure

  3. Visceral malperfusion [ Time Frame: 6 months ]
    Clinical evidences of visceral malperfusion (acute or achronic abdomen ischemia) during 6 months after procedure (Yes or No)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02726841


Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Investigators
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Study Chair: Alexander M. Chernyavskiy, MD PhD Academician Ye. Meshalkin Novosibirsk Research Institute of Circulation Pathology Ministry of Health care of Russian Federation
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Responsible Party: Dmitry Sirota, Cardiac surgeon, Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT02726841    
Other Study ID Numbers: TAAD+bare stent
First Posted: April 4, 2016    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dmitry Sirota, Meshalkin Research Institute of Pathology of Circulation:
Thoracic aorta
Abdominal aorta
Stents
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Aneurysm
Vascular Diseases
Cardiovascular Diseases