The objective of the study is to collect real-world data on patient outcomes and evaluate the safety and performance of the Lifetech Ankura™ AAA Stent Graft System, Ankura™ Cuff Stent Graft System, Ankura™ AUI Stent Graft System and ZoeTrack™ Super Stiff Guidewire.
Abdominal aortic aneurysm (AAA) is the most common true arterial aneurysm. Surgical management options for AAA include traditional Open Surgical Repair (OSR) and minimally invasive Endovascular Aneurysm Repair (EVAR). Multiple endovascular devices are commercially available for repair of AAA. Currently available endovascular grafts for infrarenal aortic repair share a bifurcated, modular design. Ankura™ Stent Graft Systems are minimally invasive endovascular devices that offer an alternative treatment for patients with AAA, which have been marketed worldwide for many years. In order to evaluate the long-term safety and performance of the investigational device from real world, this post-market clinical follow-up study is planned under the Regulation (EU) 2017/745. The study intends to enroll 162 subjects. The anticipated enrollment period is approximately 1.5 years and subjects will be followed for 3 years (36 months) post-implantation.
Study Type
OBSERVATIONAL
Enrollment
164
Patients will be implanted with Ankura™ AAA, Cuff or AUI Stent Graft System in accordance with the Instructions for Use (IFU).
MBAL Heart and Brain EAD
Pleven, Bulgaria
University Hospital for Active Treatment "Sofiamed"
Sofia, Bulgaria
Laiko - University Hospital of Athens
Athens, Greece
General University Hospital of Patras
Pátrai, Greece
Incidence of Major Adverse Events (MAE)
MAEs are defined as all-cause death, myocardial infarction, renal failure, respiratory failure, paraplegia, stroke, and intestinal ischemia.
Time frame: within 30 days post-procedure
12-month Treatment Success Rate
Rate of successful endovascular aneurysm repair with Ankura™ AAA and Cuff Stent Graft Systems or Ankura™ AUI Stent Graft system in 12 months. A successful repair should meet ALL the following requirements: 1. Technical success, defined as delivery system delivered the stent graft at the desired position, stent graft deployed successfully. 2. No aneurysm diameter dilation or aneurysm diameter dilation ≤ 5mm compared to baseline. 3. No stent graft migration or stent graft migration ≤ 10mm. 4. No re-intervention due to type I and III Endoleak. 5. No aneurysm rupture. 6. No conversion to Open Surgical Repair (OSR). 7. No stent graft thrombosis.
Time frame: 12 months post-procedure
All-cause mortality
Time frame: through 36 months post-procedure
Incidence of device-related or procedure-related SAE
Time frame: through 36 months post-procedure
Incidence of abdominal aneurysm-related or stent graft-related secondary intervention, including Endovascular Aortic Repair (EVAR) and open surgery
Time frame: through 36 months post-procedure
Incidence of stent migration (>10mm)
Time frame: at 3-6 months, 12 months, and 24 months post-procedure
Incidence of stent fracture
Time frame: at 3-6 months, 12 months, and 24 months post-procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Papageorgiou General Hospital
Thessaloniki, Greece
Ankara University Heart Center
Ankara, Turkey (Türkiye)
Ankara City Hospital
Ankara, Turkey (Türkiye)
Incidence of stent thrombosis
Time frame: at 3-6 months, 12 months, and 24 months post-procedure
Incidence of stent embolization
Time frame: through 36 months post-procedure
Immediate procedure success rate
Defined as Ankura™ stent graft is successfully implanted at the desirable place guided by Lifetech ZoeTrack™ Super Stiff Guidewire.
Time frame: immediately after the procedure
Incidence of Type I, III, IV Endoleak
Time frame: at 3-6 months, 12 months, and 24 months post-procedure
Incidence of aneurysm enlargement (>5mm, compared to baseline)
Time frame: at 3-6 months, 12 months and 24 months post-procedure
Incidence of aneurysm/vessel rupture
Time frame: through 36 months post-procedure