Ankura™ AAA Stent Graft System; Ankura™ Cuff Stent Graft System; Ankura™ AUI Stent Graft System: Patients will be implanted with Ankura™ AAA, Cuff or AUI Stent Graft System in accordance with the Instructions for Use (IFU).
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
1. Patient diagnosed with Abdominal Aortic Aneurysm (AAA), who needs endovascular aortic repair;
2. Patient's anatomy suits Ankura™ AAA and Cuff Stent Graft Systems, or AUI Stent Graft IFU requirements, which indicated by the following:
1. Adequate iliac/femoral access vessel that is compatible with the required delivery system.
2. Non-aneurysmal proximal aortic neck length ≥15mm.
3. Non-aneurysmal proximal aortic neck diameter of 18-32mm.
4. Proximal aortic neck angulation ≤ 60°.
5. Distal iliac artery anchorage zone ≥15mm.
6. Distal iliac artery diameter of i. 8-22 mm (for Ankura™ AAA and Cuff Stent Graft Systems), OR ii. 10-16 mm (for Ankura™ AUI Stent Graft System).
7. Morphology suitable for endovascular repair.
3. Patient could understand the purpose of the clinical trial, agrees to comply with the requirements of the study including the 3-year follow-up, and signed the patient informed consent, will participate in the study.
Exclusion Criteria:
1. Age\<18 years or Age\>85 years;
2. Patients' life expectancy \< 1 year;
3. Pregnant or plan to be pregnant or breast feeding;
4. Patient with any contraindications mentioned in the Ankura™ AAA and Cuff Stent Graft Systems, or in Ankura™ AUI Stent Graft system IFU:
1. Patient with acute systemic infection;
2. Patient with mesenteric blood flow mainly supplied by the inferior mesenteric artery;
3. Patient with accessory renal artery original from abdominal artery;
4. Patient who has allergic reaction to the device;
5. Patient who is not suitable for endovascular repair in vascular morphology;
6. Patient who cannot tolerate contrast agents due to renal insufficiency;
7. Patient who is allergic to contrast agent;
8. Patient's aneurysms neck has thrombus;
9. Non-aneurysmal proximal aortic neck length \<15mm;
10. Non-aneurysmal proximal aortic neck diameter \<18mm or \>32mm;
11. Proximal aortic neck angulation \> 60°;
12. Distal iliac artery anchorage zone \<15mm;
13. Distal iliac artery diameter: i. For Ankura™ AAA and Cuff Stent Graft Systems: \<8mm or \>22mm, OR ii. For Ankura™ AUI Stent Graft system: \<10mm or \>16mm.
5. Patient with traumatic aortic injury;
6. Patient with uncorrectable coagulopathy;
7. Patient with hereditary connective tissue disease, including but not limited to Marfan Syndrome or Ehlers-Danlos Syndrome;
8. Patient with concomitant thoracic aortic or thoraco-abdominal aneurysms;
9. Patient who weighs greater than 350 pounds (150kg) or cannot undergo accurate fluoroscopy examination due to obesity.
10. Acute myocardial infarction or heart failure (NYHA class III and IV), respiratory failure, malignant tumor and other serious systemic diseases.
11. Subject must not be participating in another study for an investigational drug and/or device that may clinically interfere with this study's endpoints.
12. Any condition (medical or anatomic) which makes the patient not suitable for endovascular repair according to the opinion of the investigator.
Primary outcome measure(s)
Incidence of Major Adverse Events (MAE) — within 30 days post-procedure MAEs are defined as all-cause death, myocardial infarction, renal failure, respiratory failure, paraplegia, stroke, and intestinal ischemia.
12-month Treatment Success Rate — 12 months post-procedure 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.
Trial sites (7)
Facility
City
Region
Status
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
Papageorgiou General Hospital
Thessaloniki
Greece
Ankara University Heart Center
Ankara
Turkey (Türkiye)
Ankara City Hospital
Ankara
Turkey (Türkiye)
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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