Hybrid Treatment of Type B Aortic Dissection

Aortic Dissection Type B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02726841
• Other study ID #: TAAD+bare stent
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 27, 2016
• Last updated: September 12, 2017
• Start date: January 2013
• Est. completion date: January 2020

Study information

• Verified date: September 2017
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 160
• Est. completion date: January 2020
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Dissection Type B

Intervention

Procedure:
• Open thoracoabdominal aortic repair + abdominal stenting
Thoracoabdominal aortic dissection (TAAD) repair + bare aortic stent (Djumbodis) implantation
• Classic thoracoabdominal aortic repair
Thoracoabdominal aortic dissection (TAAD) repair

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Permanent neurological events	Quantity of permanent neurological events such as stroke and paraplegia by 30th day after procedure.	30 days
Secondary	Perioperative bleeding	Volume of perioperative and postoperative bleeding in ICU	5 days after procedure
Secondary	Mortality	Postoperative mortality will be measured during 6 months after procedure	6 months
Secondary	Visceral malperfusion	Clinical evidences of visceral malperfusion (acute or achronic abdomen ischemia) during 6 months after procedure (Yes or No)	6 months