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Stent for treating aneurysms of the aorta at the level of the renal arteries.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26210
Enrollment
20
Registered
2011-04-05
Start date
2011-05-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Aneurysma aorta abdominal Aortic abdominal aneurysm fenestrated endograft gefenestreerde endograft juxtarenaal suprarenaal

Interventions

Fenestrated Anaconda endograft.

Sponsors

Medisch Spectrum twente
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 - 85 years; 2. Patient willing and available to comply with follow up requirements; 3. Patient can comply with instructions and give informed consent; 4. Life Expectancy > 2 Years; 5. AAA > 55 mm in diameter; 6. Suprarenal proximal neck diameter 18 – 31.5 mm; 7. Inadequate infrarenal aortic neck sealing zone; 8. Distal Iliac fixation site diameter = 20 mm in length; 10. Access vessels: Appropriate anatomy, at the physicians discretion, for access vessel suitability; 11. Aortic neck angulation <= 90 degrees.

Exclusion criteria

Exclusion criteria: 1. Ruptured AAA; 2. Presence of serious concomitant medical disease or infection; 3. Low operative risk for open repair; 4. Known allergy to contrast medium, nitinol or polyester; 5. Connective tissue disease; 6. ASA Grade IV or V; 7. Need for surgical reconstruction of other visceral arteries or inability to place a stent in the visceral arteries; 8. Presence of > 50% continuous calcification of proximal neck; 9. Presence of > 50% thrombus in proximal neck; 10. Other unsuitable anatomy.

Design outcomes

Primary

MeasureTime frame
Durable exclusion of juxta en suprarenal AAA.

Secondary

MeasureTime frame
1. Re-interventions; 2. Mortality; 3. Renal function; 4. Splanchnic ischemia; 5. Cardiopulmonary complications.

Contacts

Public ContactR. Meerwaldt

Medisch Spectrum Twente, Afdeling Chirurgie Postbus 50.000

r.meeraldt@mst.nl+31 (0)53 4872000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)