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Monocenter Feasibility Study using the fenestrated ANACONDA endograft for juxta- and suprarenal abdominal aorta aneurysm repair

Monocenter Feasibility Study using the fenestrated ANACONDA endograft for juxta- and suprarenal abdominal aorta aneurysm repair - FANA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36025
Enrollment
20
Registered
2011-05-26
Start date
2011-05-26
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

aorta aneursym

Interventions

ANACONDA fenestrated endograft. The operation will be performed under local, epidural or general anaesthetic in the operating theatre at the discretion of the surgeon based on individual patient st

Sponsors

Medisch Spectrum Twente
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Patients aged 18 years - 90 Years * Patient willing and available to comply with follow up requirements * Patient can comply with instructions and give informed consent * Life Expectancy > 2 Years * AAA > 55 mm in diameter * Suprarenal proximal neck diameter 18 - 31.5mm * Inadequate infrarenal aortic neck sealing zone * Distal Iliac fixation site diameter = 20 mm in length. * Access vessels: Appropriate anatomy, at the physicians discretion, for access vessel suitability * Aortic neck angulation

Exclusion criteria

Exclusion criteria: Ruptured AAA * Presence of serious concomitant medical disease or infection * Low operative risk for open repair * Known allergy to contrast medium, nitinol or polyester * Connective tissue disease * ASA Grade IV or V * Need for surgical reconstruction of other visceral arteries or inability to place stent in visceralartery * Presence of > 50% continuous calcification of proximal neck * Presence of > 50% thrombus in proximal neck * Other unsuitable anatomy

Design outcomes

Primary

MeasureTime frame
Feasibility of the fenestrated ANACONDA endograft for juxta and suprarenal aortic aneurysms: 1. Technical success (i.e. exclsuion of the aneurysm; see protocol for more information) 2. Patency of the endograft and stents 3. Endoleak 4. Migration of the endograft

Secondary

MeasureTime frame
1. Renal and mesenteric function 2. Reintervention 3. cardiopulmonary complications 4. mortality

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)