Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT05864560
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05864560
Study Brief:
Protocol Section:
NCT05864560