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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