Ankura™ AAA, Cuff and AUI Stent Graft System Post-Market Clinical Follow-Up

Last updated: February 6, 2025
Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Aneurysm

Heart Disease

Cardiovascular Disease

Treatment

Ankura™ AAA Stent Graft System; Ankura™ Cuff Stent Graft System; Ankura™ AUI Stent Graft System

Clinical Study ID

NCT05864560
LT/TS/12C-2021-02
  • Ages 18-85
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Patient diagnosed with Abdominal Aortic Aneurysm (AAA), who needs endovascularaortic repair;

  2. Patient's anatomy suits Ankura™ AAA and Cuff Stent Graft Systems, or AUI Stent GraftIFU requirements, which indicated by the following:

  3. Adequate iliac/femoral access vessel that is compatible with the requireddelivery system.

  4. Non-aneurysmal proximal aortic neck length ≥15mm.

  5. Non-aneurysmal proximal aortic neck diameter of 18-32mm.

  6. Proximal aortic neck angulation ≤ 60°.

  7. Distal iliac artery anchorage zone ≥15mm.

  8. Distal iliac artery diameter of i. 8-22 mm (for Ankura™ AAA and Cuff StentGraft Systems), OR ii. 10-16 mm (for Ankura™ AUI Stent Graft System).

  9. Morphology suitable for endovascular repair.

  10. Patient could understand the purpose of the clinical trial, agrees to comply withthe requirements of the study including the 3-year follow-up, and signed the patientinformed consent, will participate in the study.

Exclusion

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 GraftSystems, or in Ankura™ AUI Stent Graft system IFU:

  5. Patient with acute systemic infection;

  6. Patient with mesenteric blood flow mainly supplied by the inferior mesentericartery;

  7. Patient with accessory renal artery original from abdominal artery;

  8. Patient who has allergic reaction to the device;

  9. Patient who is not suitable for endovascular repair in vascular morphology;

  10. Patient who cannot tolerate contrast agents due to renal insufficiency;

  11. Patient who is allergic to contrast agent;

  12. Patient's aneurysms neck has thrombus;

  13. Non-aneurysmal proximal aortic neck length <15mm;

  14. Non-aneurysmal proximal aortic neck diameter <18mm or >32mm;

  15. Proximal aortic neck angulation > 60°;

  16. Distal iliac artery anchorage zone <15mm;

  17. 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.

  18. Patient with traumatic aortic injury;

  19. Patient with uncorrectable coagulopathy;

  20. Patient with hereditary connective tissue disease, including but not limited toMarfan Syndrome or Ehlers-Danlos Syndrome;

  21. Patient with concomitant thoracic aortic or thoraco-abdominal aneurysms;

  22. Patient who weighs greater than 350 pounds (150kg) or cannot undergo accuratefluoroscopy examination due to obesity.

  23. Acute myocardial infarction or heart failure (NYHA class III and IV), respiratoryfailure, malignant tumor and other serious systemic diseases.

  24. Subject must not be participating in another study for an investigational drugand/or device that may clinically interfere with this study's endpoints.

  25. Any condition (medical or anatomic) which makes the patient not suitable forendovascular repair according to the opinion of the investigator.

Study Design

Total Participants: 164
Treatment Group(s): 1
Primary Treatment: Ankura™ AAA Stent Graft System; Ankura™ Cuff Stent Graft System; Ankura™ AUI Stent Graft System
Phase:
Study Start date:
September 19, 2023
Estimated Completion Date:
December 31, 2027

Study Description

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.

Connect with a study center

  • MBAL Heart and Brain EAD

    Pleven, 5804
    Bulgaria

    Site Not Available

  • Military Medical Academy

    Sofia, 1606
    Bulgaria

    Active - Recruiting

  • National Hospital of Cardiology

    Sofia, 1309
    Bulgaria

    Active - Recruiting

  • University Hospital for Active Treatment "Sofiamed"

    Sofia, 1797
    Bulgaria

    Site Not Available

  • Laiko - University Hospital of Athens

    Athens, 11527
    Greece

    Site Not Available

  • General University Hospital of Patras

    Patras, 26504
    Greece

    Site Not Available

  • Papageorgiou General Hospital

    Thessaloniki, 56403
    Greece

    Site Not Available

  • Ankara City Hospital

    Ankara, 06800
    Turkey

    Site Not Available

  • Ankara University Heart Center

    Ankara, 06340
    Turkey

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.