Acute, Complicated Type B Aortic Dissection
Conditions
Interventions
Stent graft deploy
Sponsors
Cook Research Incorporated
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient is deemed suitable for inclusion in the study if the patient has an acute, complicated, Type B aortic dissection with at least one of the following characteristics : 1)Aortic rupture; or 2)Branch vessel obstruction/compromise resulting in malperfusion
Exclusion criteria
Exclusion criteria: General Exclusion Criteria 1)Age < 18 years; 2)Other medical condition (e.g., cancer, congestive heart failure) that may cause the patient to be non-compliant with the Clinical Investigation Plan, confound the results, or is associated with limited life expectancy (i.e., less than 2 years); 3)Pregnant, breast-feeding, or planning on becoming pregnant within 60 months; 4)Unwilling or unable to comply with the follow-up schedule; 5)Inability or refusal to give informed consent; or 6)Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.) *Additionally, there is Medical Exclusion Criteria and Anatomical Exclusion Criteria, too.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary safety endpoint will be rate of freedom from major adverse events at 30 days. The primary effectiveness endpoint will be the survival rate at 30 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| ability to deliver and deploy the device(s), clinical utility measures, major adverse events, retrograde progression of dissection, changes in true and false lumen sizes, presence of and sources for false lumen flow, extent of false lumen thrombosis, reinterventions, and device integrity | — |
Countries
Japan,North America
Contacts
Public ContactEmiko Mori
Cook Incorporated Clinical Affairs
Outcome results
None listed