Beyond a certain threshold diameter, Abdominal aortic aneurysms (AAA) are treated by open surgical repair or, more often by endovascular aortic aneurysm repair (EVAR). The latter involves implantation of a stent-graft and thereby exclusion of the AAA from the blood circuit. Small vessels supplying parts of the bowel or the spine are regularly covered. In a quarter of patients, this may result in an inversion of blood flow in the mentioned vessels, leading to persistent blood flow within the AAA, referred to as type II endoleak (T2EL). Occurrence of T2EL is associated with complications like AAA growth or even rupture. Secondary interventions to treat T2EL often fail and may be highly invasive. Various risk factors for T2EL have been described. This enables prediction whether a patient is at high risk for T2EL after EVAR. Deployment of metal coils in the aneurysm sac as part of the EVAR procedure can reduce the risk for T2EL.The present study aims to assess the efficacy of sac embolization during EVAR to prevent T2EL.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
100
Patients are treated with standard EVAR with additional coiling of the aneurysm sac. The distinct type of coils used is not predefined.
TUM Klinikum Rechts der Isar, Klinik und Poliklinik für Vaskuläre und Endovaskuläre Chirurgie
Munich, Bavaria, Germany
RECRUITINGType II Endoleak at 12 months after procedure
Evaluation of the T2EL proportion of the intervention group as compared to the control group at 12 months after EVAR treatment as measured by CEUS and/or CT-A
Time frame: 12 months
Type II Endoleak during follow up
T2EL 2-4 days after EVAR treatment detected by CEUS and/or CT-A
Time frame: 2-4 days
Type II Endoleak during follow up
T2EL 30 days after EVAR treatment detected by CEUS and/or CT-A
Time frame: 30 days
Type II Endoleak during follow up
T2EL 6 months after EVAR treatment detected by CEUS and/or CT-A
Time frame: 6 months
Re-intervention
Rates of any re-intervention (for endoleaks, occlusions, graft infection, graft migration)
Time frame: 12 months
Type I or III Endoleak
Occurrence of any EL Type I or III
Time frame: 12 months
AAA morphology
Changes of AAA diameter as measured by CT-A in comparison to initial CT-A scan at V0
Time frame: 12 months
AAA morphology
Changes of AAA volume as measured by CT-A in comparison to initial CT-A scan at V0
Time frame: 12 months
AAA rupture
Rate of AAA rupture 12 months after EVAR treatment
Time frame: 12 months
Mortality
Mortality (aneurysm-related/not aneurysm related) 12 months after EVAR treatment
Time frame: 12 months
life quality
Change in quality of life assessed by SF-36 from baseline to 12 months after EVAR treat-ment
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.