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
Verified date | September 2017 |
Source | Meshalkin Research Institute of Pathology of Circulation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Authors hypothesize that thoracoabdominal aortic repair combined with bare metal stent implantation is superior over standard thoracoabdominal aortic repair.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Meshalkin Research Institute of Pathology of Circulation |
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 |
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