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Abdominal Aortic AneurysmNCT05864560

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

An observational study of Abdominal Aortic Aneurysm, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 7 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Abdominal Aortic Aneurysm
What is being tested?
Ankura™ AAA Stent Graft System; Ankura™ Cuff Stent Graft System; Ankura™ AUI Stent Graft System
Type of treatment
Medical device
How many people
164 participants
Where
7 sitesin 3 countries
Study dates
15 Sep 2023to 30 Sep 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patient diagnosed with Abdominal Aortic Aneurysm, who needs endovascular aortic repair.

Who may be able to join

  • 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°.
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  • 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 join

  • Age<18 years or Age>85 years;
  • Patients' life expectancy < 1 year;
  • Pregnant or plan to be pregnant or breast feeding;
  • 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;
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  • 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 traumatic aortic injury;
  • Patient with uncorrectable coagulopathy;
  • Patient with hereditary connective tissue disease, including but not limited to Marfan Syndrome or Ehlers-Danlos Syndrome;
  • Patient with concomitant thoracic aortic or thoraco-abdominal aneurysms；
  • Patient who weighs greater than 350 pounds (150kg) or cannot undergo accurate fluoroscopy examination due to obesity.
  • Acute myocardial infarction or heart failure (NYHA class III and IV), respiratory failure, malignant tumor and other serious systemic diseases.
  • Subject must not be participating in another study for an investigational drug and/or device that may clinically interfere with this study's endpoints.
  • Any condition (medical or anatomic) which makes the patient not suitable for endovascular repair according to the opinion of the investigator.

Trial locations and contacts

7 sites in 3 countries.

7 sites in 3 countries

Greece3 sites

  • Laiko - University Hospital of Athens

    Athens, 11527

  • General University Hospital of Patras

    Pátrai, 26504

  • Papageorgiou General Hospital

    Thessaloniki, 56403

Other trials in Greece

Bulgaria2 sites

  • MBAL Heart and Brain EAD

    Pleven, 5804

  • University Hospital for Active Treatment "Sofiamed"

    Sofia, 1797

Other trials in Bulgaria

Turkey (Türkiye)2 sites

  • Ankara University Heart Center

    Ankara, 06340

  • Ankara City Hospital

    Ankara, 06800

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the detailed 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.

Being tested
Ankura™ AAA Stent Graft System; Ankura™ Cuff Stent Graft System; Ankura™ AUI Stent Graft System
Keywords
Lifetech, Ankura, Endovascular Aneurysm Repair, Abdominal Aortic Aneurysm, Stent Graft System, EVAR, AAA
Medical subject headings
Aortic Aneurysm, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Patients will be implanted with Ankura™ AAA, Cuff or AUI Stent Graft System in accordance with the Instructions for Use (IFU).

Study groups in NCT05864560
Study groupRoleWhat they receive
AAA SubjectsPatient diagnosed with Abdominal Aortic Aneurysm, who needs endovascular aortic repair.
Receives: Device: Ankura™ AAA Stent Graft System; Ankura™ Cuff Stent Graft System; Ankura™ AUI Stent Graft System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Major Adverse Events (MAE)

    MAEs are defined as all-cause death, myocardial infarction, renal failure, respiratory failure, paraplegia, stroke, and intestinal ischemia.

    Measured: within 30 days post-procedure

  2. 12-month Treatment Success Rate

    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.

    Measured: 12 months post-procedure

Secondary outcomes (11)

  1. All-cause mortality

    Measured: through 36 months post-procedure

  2. Incidence of device-related or procedure-related SAE

    Measured: through 36 months post-procedure

  3. Incidence of abdominal aneurysm-related or stent graft-related secondary intervention, including Endovascular Aortic Repair (EVAR) and open surgery

    Measured: through 36 months post-procedure

  4. Incidence of stent migration (>10mm)

    Measured: at 3-6 months, 12 months, and 24 months post-procedure

  5. Incidence of stent fracture

    Measured: at 3-6 months, 12 months, and 24 months post-procedure

  6. Incidence of stent thrombosis

    Measured: at 3-6 months, 12 months, and 24 months post-procedure

  7. Incidence of stent embolization

    Measured: through 36 months post-procedure

  8. Immediate procedure success rate

    Defined as Ankura™ stent graft is successfully implanted at the desirable place guided by Lifetech ZoeTrack™ Super Stiff Guidewire.

    Measured: immediately after the procedure

  9. Incidence of Type I, III, IV Endoleak

    Measured: at 3-6 months, 12 months, and 24 months post-procedure

  10. Incidence of aneurysm enlargement (>5mm, compared to baseline)

    Measured: at 3-6 months, 12 months and 24 months post-procedure

  11. Incidence of aneurysm/vessel rupture

    Measured: through 36 months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2023
  2. Study start15 Sep 2023
  3. Primary completion30 Aug 2026 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05864560
Sponsor's protocol ID
LT/TS/12C-2021-02
Status last verified
May 2026
First submitted
9 May 2023
Last updated
26 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Abdominal Aortic Aneurysm, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 7 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Greece, Bulgaria, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Major Adverse Events (MAE) (time frame: within 30 days post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05864560.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.

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