Abdominal Aortic Aneurysm, Endoleak
Conditions
Keywords
Abdominal Aortic Aneurysm, Endoleak, Endovascular aortic aneurysm repair, Coiling, Endoleak Type II
Brief summary
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.
Interventions
PROCEDURECoil embolization of aneurysm sac
Patients are treated with standard EVAR with additional coiling of the aneurysm sac. The distinct type of coils used is not predefined.
Sponsors
Univ.-Prof. Dr. Dr. med. Daniela Branzan
Technical University of Munich
St. Josefs-Hospital Wiesbaden GmbH
University Hospital Augsburg
University Hospital Carl Gustav Carus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
randomized controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Infrarenal AAA ≥50 mm maximum diameter * Indication for EVAR within IFU of company * Presence of one or both high risk criteria on CT-A: ≥5 patent efferent vessels (inferior mesenteric and/or lumbar artery, and/or median sacral artery) or \<40% thrombus at largest AAA diameter
Exclusion criteria
* Ruptured AAA * Fenestrated or branched EVAR * Concomitant iliac artery aneurysm * Non-ability to adhere to the FU protocol * Lack of consent * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Type II Endoleak at 12 months after procedure | 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Type II Endoleak during follow up | 2-4 days | T2EL 2-4 days after EVAR treatment detected by CEUS and/or CT-A |
| Re-intervention | 12 months | Rates of any re-intervention (for endoleaks, occlusions, graft infection, graft migration) |
| Type I or III Endoleak | 12 months | Occurrence of any EL Type I or III |
| AAA morphology | 12 months | Changes of AAA diameter as measured by CT-A in comparison to initial CT-A scan at V0 |
| AAA rupture | 12 months | Rate of AAA rupture 12 months after EVAR treatment |
| Mortality | 12 months | Mortality (aneurysm-related/not aneurysm related) 12 months after EVAR treatment |
| life quality | 12 months | Change in quality of life assessed by SF-36 from baseline to 12 months after EVAR treat-ment |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORDaniela Branzan, Univ.-Prof. Dr. Dr. med.
Technical University Munich
Outcome results
None listed