To determine the safety and efficacy of the BMFM® kit in the use for the endovascular treatment of aortic aneurysms involving iliac arteries. The BMFM® kit is an adaptation of the aortic MFM® to the aortoiliac bifurcation morphology. It should be noted that the aortic MFM® has CE mark approval for the aortic aneurysm treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
Patients must meet ALL of the following criteria:
* Age over 18
* Life expectancy \> 12 months
* Aortic aneurysms involving iliac arteries
* Healthy proximal and distal landing zone
* Adequate arterial access
* Healthy branches and collaterals (no stenosis or previously treated by angioplasty)
* Informed consent understood, signed and patient agrees to all follow-up visits
Exclusion Criteria:
Patients will be excluded if ANY of the following conditions apply:
* Aneurysm rupture, impending or contained rupture
* Aortic dissection
* Aortic root aneurysm
* Pleural effusion
* Prior all surgical procedure within 30 days unless procedure is in preparation for device implantation or planned within 30 days post stent deployment
* Myocardial infarction or cerebral vascular accident within 6 weeks of treatment
* Presence/suspicion of connective tissue disorders, for example, Marfan or Ehlers-Danlos etc.
* Contraindications to the anticoagulant or/ and antiplatelet medications
* Allergic reaction to a contrast agent
* Patient with undergoing or planned chemotherapy
* History of bleeding disorder (coagulopathy) or thrombophilia
* Shaggy aorta
* Takayasu's arteritis
* Presence/suspicion of infection (for example: mycotic aorta)
* The use of the MFM® with stent-grafts or previously implanted stent-grafts
* Pregnant or breastfeeding woman
* Patients included in another clinical study
What they're measuring
1
Number of patients with unruptured aneurysm
Timeframe: 12 months
2
Mortality 30 days, 6 months and 1 year aneurysm-related