Hybrid Treatment of Type B Aortic Dissection

Study Overview
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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.

Official Title
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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

Conditions
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Aortic Dissection Type B

Intervention / Treatment
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* Procedure: Open thoracoabdominal aortic repair + abdominal stenting
* Procedure: Classic thoracoabdominal aortic repair


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracic aorta, Abdominal aorta, Stents