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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02726841
Other study ID # TAAD+bare stent
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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Not yet recruiting NCT05874206 - CRATOS - Evaluation of Cratos™ Branch Stent Graft System in Treatment of Descending Aorta Lesions N/A
Active, not recruiting NCT03033771 - Dragon Study Europe N/A
Recruiting NCT03001739 - Intensive Blood PRessure Control in Patients With Acute Type B AortIc Dissection Phase 1
Active, not recruiting NCT03033043 - Study of the RelayPro Thoracic Stent-Graft in Subjects With an Acute, Complicated Type B Aortic Dissection N/A