Hybrid Treatment of Type B Aortic Dissection

Not Applicable

• Conditions: Aortic Dissection Type B
• Interventions: Procedure: Open thoracoabdominal aortic repair + abdominal stenting; Procedure: Classic thoracoabdominal aortic repair

• Registration Number: NCT02726841
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-01
• Study First Submitted: 2016-01-27
• Study First Submitted QC: 2016-04-01
• Study First Posted: 2016-04-04
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-12
• Last Update Posted: 2017-09-13
• Primary Completion: 2019-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hybrid TAAD repair	Open thoracoabdominal aortic repair + abdominal stenting	The group includes patients who underwent open thoracoabdominal aortic repair + abdominal stenting.
Conventional TAAD repair	Classic thoracoabdominal aortic repair	The group includes patients who underwent classic thoracoabdominal aortic repair with dacron prosthesis.

Primary Outcome Measures

Name	Time	Method
Permanent neurological events	30 days	Quantity of permanent neurological events such as stroke and paraplegia by 30th day after procedure.

Secondary Outcome Measures

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