NCT05864560

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

Ankura™ AAA, Cuff and AUI Stent Graft System Post-Market Clinical Follow-Up: A Multi-center, Prospective, Single-arm, Open-label, Post-market Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 164 (actual)
• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Abdominal Aortic Aneurysm

Interventions

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

Timeline

• Start date: 2023-09-19
• Primary completion: 2026-03-01
• Completion: 2027-12-01
• First posted: 2023-05-18
• Last updated: 2026-03-19

Locations

7 sites across 3 countries: Bulgaria, Greece, Turkey (Türkiye)