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This randomized controlled trial aim to determine the impact on renal function after treatment for infrarenal abdominal aortic aneurysm (AAA) with stentgrafts either with active supra- or infrarenal fixation.
This randomized controlled trial aim to determine the impact on renal function after treatment for infrarenal abdominal aortic aneurysm with stentgrafts either with active supra- or infrarenal fixation. Individuals are planned to be included throughout Scandinavia. After inclusion in the study, baseline data is collected and computerized randomization between the two stent graft fixation types is performed. Follow-up will be scheduled after 1 month and 1,3 and 5 years. Analyses of blood samples to determine renal function are undertaken together with CT scans to detect stentgraft performance at all follow-up visits alongside assessments of health-related quality of life questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suprarenal | Experimental | Individuals that are treated with a suprarenal stentgraft for a previously diagnosed AAA. |
|
| Infrarenal | Active Comparator | Individuals that are treated with an infrarenal stentgraft for a previously diagnosed AAA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stentgraft | Device | Stentgraft treatment for AAA. Comparison between supra vs infrarenal fixation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with decreased renal function (composite endpoint together with the endpoint below) | Decrease of more than 20 percent in estimated Glomerular Filtration Rate (eGFR) after stentgraft treatment. | Change between baseline renal function and at 3 years. |
| Number of participants with new renal infarct | Diagnosed new renal infarct on CT scan after treatment | Change in numbers of new renal infarcts between baseline and at 3 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with decreased renal function and new renal infarct (Analysis of the individual components of the primary composite endpoint at 1, 3 and 5 years). | Analysis of individual endpoints (decrease of more than 20 percent in estimated Glomerular Filtration Rate (eGFR) after stentgraft treatment and diagnosed new renal infarct on CT scan after treatment). | From treatment and 1, 3 and 5 years postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with migration (Safety endpoint composite together with the endpoints below) | Migration (stentgraft migration more than 3mm) postoperatively at 1 month, 1, 3 and 5 years. | From treatment and 1, 3 and 5 years postoperatively |
| Number of participants with diagnosed endoleak |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Per Skoog, M.D | Contact | +46316021000 | per.skoog@vgregion.se | |
| Joakim Nordanstig, M.D | Contact | +46316021000 | joakim.nordanstig@vgregion.se |
| Name | Affiliation | Role |
|---|---|---|
| Sophie Lindgren, M.D | Department of Hybrid and Interventional Surgery, Sahlgrenska University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Recruiting | Gothenburg | VastraGotaland | Sweden |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Randomized controlled, parallel group, partly blinded clinical study.
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The type of stentgraft is masked for participants, investigators and outcome assessors as the journal chart and information about implanted device are made not accessible for the above mentioned individuals, and all data will be gathered in an Electronic Case Report Form (eCRF) with stentgraft information masked.
| Number of participants with decreased score in quality of life-questionnaire | Change in life quality questionnaire (Research and development questionnaire 36 (RAND-36)) one and three years after surgery compared with baseline data collected prior to surgery. Score in the scale are between 0 and 100 and decreased score indicate worse outcome. | From treatment and 1 and 3 years postoperatively |
| Number of participants with stentgraft thrombosis | Occurence of stentgraft thrombosis postoperatively at 1 month, 1, 3 and 5 years. | From treatment and 1, 3 and 5 years postoperatively |
| Number of participants with aneurysm related mortality | Aneurysm related mortality postoperatively at 1 month, 1, 3 and 5 years. | From treatment and 1, 3 and 5 years postoperatively |
| Number of participants with aneurysm related hospitalizations | Aneurysm related hospitalizations postoperatively at 1 month, 1, 3 and 5 years. | From treatment and 1, 3 and 5 years postoperatively |
| Number of participants with continuing aneurysm growth | Continuing aneurysm growth postoperatively at 1 month, 1, 3 and 5 years. | From treatment and 1, 3 and 5 years postoperatively |
| Number of participants with new diagnosis of cancer | New diagnosis of cancer postoperatively at 1 month, 1, 3 and 5 years. | From treatment and 1, 3 and 5 years postoperatively |
Re-intervention for endoleak postoperatively at 1 month, 1, 3 and 5 years. |
| From treatment and 1, 3 and 5 years postoperatively |
| Number of participants with aortic rupture | Occurence of postoperative aortic rupture postoperatively at 1 month, 1, 3 and 5 years. | From treatment and 1, 3 and 5 years postoperatively |
| Number of participants with renal artery thrombosis | Postoperative renal artery thrombosis postoperatively at 1 month, 1, 3 and 5 years. | From treatment and 1, 3 and 5 years postoperatively |
| Number of participants with renal artery stenosis | Occurence of postoperative renal artery stenosis postoperatively at 1 month, 1, 3 and 5 years. | From treatment and 1, 3 and 5 years postoperatively |
| D001018 |
| Aortic Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |