Hybrid Treatment of Type B Aortic Dissection

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02726841

Enrollment

160

Registered

2016-04-04

Start date

2013-01-31

Completion date

2020-01-31

Last updated

2017-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Dissection Type B

Keywords

Thoracic aorta, Abdominal aorta, Stents

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.

Interventions

PROCEDUREOpen thoracoabdominal aortic repair + abdominal stenting

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

PROCEDUREClassic thoracoabdominal aortic repair

Thoracoabdominal aortic dissection (TAAD) repair

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Perioperative bleeding	5 days after procedure	Volume of perioperative and postoperative bleeding in ICU
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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026