Abdominal aortic aneurysm Abdominal aortic aneurysm
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: This study will include: 1. patients with an AAA diameter >=40mm and treated by watchful waiting strategy; 2. patients planned to undergo EVAR; 3. patients who underwent EVAR in past years.
Exclusion criteria
Exclusion criteria: Main exclusion criteria: patients with saccular abdominal aortic aneurysm, isolated iliac artery aneurysm, traumatic aneurysm, anastomotic aneurysm and infectious aneurysm, clinical diagnosed thoracic aneurysm, dialysis dependent patients, women of childbearing age or patients with coexistent condition with life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study endpoint is volume of the aneurysm sac, measured repeatedly by CT scan imaging during 24 months of follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include maximal diameter and length of the aneurysm, all-cause mortality, quality of life and depression and: - AAA-related adverse events in watchful waiting group: AAA related death, AAA rupture, or any AAA-related intervention. - AAA-related adverse events in EVAR patients: direct (type 1 or 3) or undetermined type endoleaks, migration >10 mm, device integrity failure, AAA-related death, late postimplantation AAA rupture, or any AAA-related secondary intervention. - Cardiovascular events: i.e. cardiovascular death, myocardial infarction, percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG). | — |
Countries
Netherlands
Contacts
Erasmus MC, Universitair Medisch Centrum Rotterdam