Hybrid Treatment of Type B Aortic Dissection

NCT ID: NCT02726841

Last Updated: 2017-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2020-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Aortic Dissection Type B

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Hybrid TAAD repair

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

Group Type EXPERIMENTAL

Open thoracoabdominal aortic repair + abdominal stenting

Intervention Type PROCEDURE

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

Conventional TAAD repair

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

Group Type ACTIVE_COMPARATOR

Classic thoracoabdominal aortic repair

Intervention Type PROCEDURE

Thoracoabdominal aortic dissection (TAAD) repair

Interventions

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Open thoracoabdominal aortic repair + abdominal stenting

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

Intervention Type PROCEDURE

Classic thoracoabdominal aortic repair

Thoracoabdominal aortic dissection (TAAD) repair

Intervention Type PROCEDURE

Other Intervention Names

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Hybrid thoracoabdominal aortic repair Conventional TAAD repair

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role lead

Responsible Party

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Dmitry Sirota

Cardiac surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexander M. Chernyavskiy, MD PhD

Role: STUDY_CHAIR

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

Other Identifiers

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TAAD+bare stent

Identifier Type: -

Identifier Source: org_study_id

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