Active, not recruitingNo phase
Ankura™ AAA, Cuff and AUI Stent Graft System Post-Market Clinical Follow-Up
Key facts
- Who runs it
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Where
- Bulgaria, Greece, and Türkiye7 sites in 3 countriesChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 164 people enrolled
- Started
- 15 Sept 2023
- Expected to end
- 30 Sept 2028
- Type of study
- Observational
- Treatments tested
- Ankura™ AAA Stent Graft System; Ankura™ Cuff Stent Graft System; Ankura™ AUI Stent Graft System
- Record updated
- 26 May 2026
Who can take part
- Age
- 18 years to 85 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- Patient diagnosed with Abdominal Aortic Aneurysm (AAA), who needs endovascular aortic repair
- Patient's anatomy suits Ankura™ AAA and Cuff Stent Graft Systems, or AUI Stent Graft IFU requirements, which indicated by the following:; Adequate iliac/femoral access vessel that is compatible with the required delivery system; Non-aneurysmal proximal aortic neck length ≥15mm; Non-aneurysmal proximal aortic neck diameter of 18-32mm; Proximal aortic neck angulation ≤ 60°; Distal iliac artery anchorage zone ≥15mm; 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); Morphology suitable for endovascular repair
- 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
Who cannot take part
- Patient with concomitant thoracic aortic or thoraco-abdominal aneurysms;
- Subject must not be participating in another study for an investigational drug and/or device that may clinically interfere with this study's endpoints
- Patient with any contraindications mentioned in the Ankura™ AAA and Cuff Stent Graft Systems, or in Ankura™ AUI Stent Graft system IFU:; Patient with acute systemic infection; Patient with mesenteric blood flow mainly supplied by the inferior mesenteric artery; Patient with accessory renal artery original from abdominal artery; Patient who has allergic reaction to the device; Patient who is not suitable for endovascular repair in vascular morphology; Patient who cannot tolerate contrast agents due to renal insufficiency; Patient who is allergic to contrast agent; Patient's aneurysms neck has thrombus; Non-aneurysmal proximal aortic neck length <15mm; Non-aneurysmal proximal aortic neck diameter <18mm or >32mm; Proximal aortic neck angulation > 60°; Distal iliac artery anchorage zone <15mm; 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
- Patient with hereditary connective tissue disease, including but not limited to Marfan Syndrome or Ehlers-Danlos Syndrome
- Acute myocardial infarction or heart failure (NYHA class III and IV), respiratory failure, malignant tumor and other serious systemic diseases
- Any condition (medical or anatomic) which makes the patient not suitable for endovascular repair according to the opinion of the investigator
- Age<18 years or Age>85 years
- Patients' life expectancy < 1 year
- Pregnant or plan to be pregnant or breast feeding
- Patient with traumatic aortic injury
- Patient with uncorrectable coagulopathy
- Patient who weighs greater than 350 pounds (150kg) or cannot undergo accurate fluoroscopy examination due to obesity
This trial has no sites in United States.
It has sites in 3 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The group in the trial
- AAA Subjects
Patient diagnosed with Abdominal Aortic Aneurysm, who needs endovascular aortic repair.
Treatment: Ankura™ AAA Stent Graft System; Ankura™ Cuff Stent Graft System; Ankura™ AUI Stent Graft System
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Ankura™ AAA, Cuff and AUI Stent Graft System Post-Market Clinical Follow-Up: A Multi-center, Prospective, Single-arm, Open-label, Post-market Study
- Record updated
- 26 May 2026