Hellenic Registry of Ovation Alto™ Abdominal Stent Graft System

Larissa University Hospital

Status: Unknown

Conditions: Abdominal Aortic Aneurysm

Treatments: Device: Ovation Alto™ Abdominal Stent Graft System

Study type: Observational

Funder types: Other

Identifiers

NCT05172830

986152150

Details and patient eligibility

About

This is a Hellenic Registry including both retrospective and prospective subjects receiving the Ovation Alto™ Abdominal Stent Graft System ("Ovation Alto™ Abdominal Stent Graft System Post-Market Study") in the treatment of abdominal aortic aneurysms (AAA). The Ovation Alto™ Hellenic Registry is intended to expand the clinical knowledge base by collecting data on subjects treated with the Ovation Alto™ Abdominal Stent Graft System in actual clinical practice during the first post-operative year.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is > 18 years of age
• Both IFU and non-adherence to IFU
• Subject intends to electively receive the Ovation Alto™ Abdominal Stent Graft System
• Subject has the ability and willingness to comply with all follow-up exams as indicated in clinical investigation plan

Exclusion criteria

• Subject's current participation in a concurrent randomized control trial (RCT) or investigational device/drug study which could confound study results.
• Life expectancy less than 1 year
• Pregnancy
• Subjects with poor renal function as indicated by a serum creatinine > 2.5mg/dl.

Trial design

60 participants in 1 patient group

Group/Cohort

Description:

Ovation Alto™ Abdominal Stent Graft System Eligible patients must meet all of the inclusion criteria and none of the exclusion criteria.

Treatment:

Device: Ovation Alto™ Abdominal Stent Graft System