fusiform or saccular aneurysms
Conditions
Interventions
Stent graft custody with catheter
Sponsors
Cook Japan Incorporated
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Descending thoracic fusiform aneurysm with diameter >5.0 cm 2) Descending thoracic fusiform aneurysm with a history of growth >0.5 cm per year 3) Descending thoracic saccular aneurysm >10 mm in depth and >20 mm in diameter
Exclusion criteria
Exclusion criteria: <General Exclusion Criteria> 1) Less than 20 years of age 2) Life expectancy less than 2 years 3) Pregnant or breastfeeding or planning on becoming pregnant within 60 months 4) Unwilling to company with the follow-up schedule 5) Inability or refusal to give informed consent 6) Less than 30 days beyond primary endpoint for other investigative drug or device study *Additionally, there is Medical Exclusion Criteria and Anatomical Exclusion Criteria, too.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device success, Procedural time, Condit usage during the procedure, Clinical utility measures, Morbidity, including the composite rate of major adverse events, Endleak, change in aneurysm size, migration, device patency, device integrity | — |
Countries
Japan,North America,Europe
Contacts
Public ContactYasuhito Shimizu
Cook Japan Incorporated Clinical Affairs
Outcome results
None listed