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

NCT05864560 | Active Not Recruiting

• 1 other identifier: LT/TS/12C-2021-02
• Study Type: observational
• Target: 164
• Locations: 3 countries
• Sites: 7

Brief 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.

Conditions

Abdominal Aortic Aneurysm

Keywords

Lifetech; Ankura; Endovascular Aneurysm Repair; Abdominal Aortic Aneurysm; Stent Graft System; EVAR; AAA

Outcome Measures

Primary Outcomes (2)

• Incidence of Major Adverse Events (MAE)

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

  within 30 days post-procedure

• 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.

  12 months post-procedure

Secondary Outcomes (11)

• All-cause mortality

  through 36 months post-procedure

• Incidence of device-related or procedure-related SAE

  through 36 months post-procedure

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

  through 36 months post-procedure

• Incidence of stent migration (>10mm)

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

• Incidence of stent fracture

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

Study Arms (1)

AAA Subjects

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

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

Interventions

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

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

AAA Subjects

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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°;

Sponsors & Collaborators

• Lifetech Scientific (Shenzhen) Co., Ltd.: lead

Study Sites (7)

MBAL Heart and Brain EAD

Pleven, 5804, Bulgaria

Location

University Hospital for Active Treatment "Sofiamed"

Sofia, 1797, Bulgaria

Location

Laiko - University Hospital of Athens

Athens, 11527, Greece

Location

General University Hospital of Patras

Pátrai, 26504, Greece

Location

Papageorgiou General Hospital

Thessaloniki, 56403, Greece

Location

Ankara University Heart Center

Ankara, 06340, Turkey (Türkiye)

Location

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 18, 2023
• Study Start: September 15, 2023
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 30, 2028
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2); BU (2); GR (3)