None listed
Conditions
Brief summary
Abdominal aortic aneurysm (AAA) is a severe and potentially life-threatening condition, with increasing incidence due to the aging population. Traditionally this has been treated by open surgery, which carries high perioperative risks of disability or death. With the advent of endovascular stenting (EVAR), which involves placing a stent-graft inside the aorta for exclusion of the anuerysm, for the treatment of this condition, the invasiveness and subsequently the risk has been greatly reduced. However the suitability of patients for EVAR is limited by a narrow set of anatomical prerequisites, mostly which concern the neck region (the segment of aorta between renal arteries and the aneurysm) for satisfactory treatment. As a result patients suffering from AAA with hostile neck features are frequently excluded from the benefits of EVAR. Usage outside recommended anatomies has resulted in mixed results in different studies, while some studies finding that hostile neck features contribute to late complications after EVAR such as endoleak (persistent leakage of blood into the sac despite EVAR placement), and consequently, aneurysm sac enlargement and late rupture. We propose that using the Ovation™ system which utilizes the O-ring sealing technology can provide a customized seal to the aortic neck region, thereby reducing endoleak and other complications.
Interventions
Endovascular aortic repair (EVAR) using the Ovation™ Device
It involves placement of the Ovation™ Device (a modular stent-graft device) for repair of the infrarenal AAA. The device seals the proximal aortic neck by using polymer to infuse the O-rings in order to achieve a customised seal without exerting outward radial force to maintain the seal.
The approximate duration of intervention is 2-3 hours which is similar to usual EVAR with other modular stent-graft systems.
The intervention will be
Endovascular aortic repair (EVAR) using the Ovation™ Device It involves placement of the Ovation™ Device (a modular stent-graft device) for repair of the infrarenal AAA. The device seals the proximal aortic neck by using polymer to infuse the O-rings in order to achieve a customised seal without exerting outward radial force to maintain the seal. The approximate duration of intervention is 2-3 hours which is similar to usual EVAR with other modular stent-graft systems. The intervention will be performed by the principle investigator (PI). The PI is a Vascular Surgeon.
Sponsors
Yih Chun Ling Patricia
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age of 18 years and above 2. Infrarenal abdominal aortic aneurysm indicated and feasible for endovascular repair: a. Aortic aneurysms of 5cm and above b. Aortic aneurysms with rapid increase in size (>5mm in 6 months or >10mm in 1 year) c. Aneurysm anatomy otherwise suitable for EVAR 3. Hostile neck features: a. Infrarenal angulation of greater than or equal to 60 degrees b. Infrarenal neck length of >5 but <15mm c. Reversed taper neck (gradual neck dilatation of >2mm within the first 10mm after the lowest renal artery) d. greater than or equal to 50% circumferential proximal neck thrombus of greater than or equal to 2mm thick e. greater than or equal to 50% circumferential calcified neck f. Neck diameter greater than or equal to 28mm but less than or equal to 30mm 4. Consent to EVAR
Exclusion criteria
1. Patient unable to provide informed consent 2. Metastatic malignancy or other terminal medical condition 3. Limited life expectancy (<6 months) 4. Pregnancy
Outcome results
None listed