Hybrid Treatment of Type B Aortic Dissection

Meshalkin Research Institute of Pathology of Circulation160 enrolled

Overview

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

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

160

Conditions

Aortic Dissection Type B

Interventions

Open thoracoabdominal aortic repair + abdominal stentingPROCEDURE

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

Classic thoracoabdominal aortic repairPROCEDURE

Thoracoabdominal aortic dissection (TAAD) repair

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Permanent neurological events

Quantity of permanent neurological events such as stroke and paraplegia by 30th day after procedure.

Time frame: 30 days

Secondary Outcomes

Perioperative bleeding

Volume of perioperative and postoperative bleeding in ICU

Time frame: 5 days after procedure

Mortality

Postoperative mortality will be measured during 6 months after procedure

Time frame: 6 months

Visceral malperfusion

Clinical evidences of visceral malperfusion (acute or achronic abdomen ischemia) during 6 months after procedure (Yes or No)

Time frame: 6 months

Data from ClinicalTrials.gov

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