|- candidate number||9305|
|- NTR Number||NTR2842|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-apr-2011|
|- Secondary IDs||H1104 METc MST|
|- Public Title||Stent for treating aneurysms of the aorta at the level of the renal arteries.|
|- Scientific Title||Monocenter Feasibility Study using the fenestrated ANACONDA endograft for juxta- and suprarenal abdominal aorta aneurysm repair.|
|- hypothesis||The fenestrated Anaconda endograft is safe for durable exclusion of juxta and suprarenal AAA.|
|- Healt Condition(s) or Problem(s) studied||Abdominal Aortic Aneurysm, Fenestrated endograft, Juxtarenal, Suprarenal|
|- 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 < =17 mm;
9. Distal Iliac fixation site >= 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||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.
|- mec approval received||no|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||Single arm|
|- planned startdate ||1-mei-2011|
|- planned closingdate||1-mei-2013|
|- Target number of participants||20|
|- Interventions||Fenestrated Anaconda endograft.|
|- Primary outcome||Durable exclusion of juxta en suprarenal AAA.|
|- Secondary outcome||1. Re-interventions;|
3. Renal function;
4. Splanchnic ischemia;
5. Cardiopulmonary complications.
|- Timepoints||1. Interim analysis after each 10 patients;|
2. Interim analysis after 1 year, of all patients;
3. Analysis of the results after 2 and 4 years, before publication.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. R. Meerwaldt|
|- CONTACT for SCIENTIFIC QUERIES||Dr. R. Meerwaldt|
|- Sponsor/Initiator ||Medisch Spectrum Twente|
(Source(s) of Monetary or Material Support)
|Medisch Spectrum Twente|
|- Brief summary||Rationale: |
Juxta- and suprarenal abdominal aortic aneurysms (AAA) are traditionally treated by open repair. Fenestrated endovascular repair offers an alternative to open repair and has been associated with a lower mortality rate. The Anaconda endograft is effective and safe in treating infrarenal AAA.
To analyse the safety and effectiveness of the fenestrated Anaconda endograft in treating juxta- and suprarenal AAA.
Monocenter feasibility study of the fenestrated Anaconda endograft.
Patients with juxta- and suprarenal AAA > 55mm.
Treating juxta- and suprarenal AAA with the fenestrated Anaconda endograft.
Main study parameters/endpoints:
Technical succes of excluding the AAA, patency migration and endoleak rates of the endograft, renal function, cardiopulmonary complications, mortality.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The fenestrated Anaconda endograft has not yet been analyzed in treating juxta- and suprarenal AAA. There is a risk that this endograft is not able to effectively exclude these AAA. In such a case, it may be necessary to treat these AAA with open repair. Renal function deterioration has been described using fenestrated endografts. Overall, fenestrated endografts seem to have a lower morbidity and mortality rate compared to the open repair procedure, which is an obvious benefit for these patients.
|- Main changes (audit trail)|
|- RECORD||5-apr-2011 - 16-apr-2011|