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NOT YET RECRUITING
NCT07754240
NA

A Clinical Investigational Study of Ankura™ II AAA, IE and AE Stent Graft System for Endovascular Treatment of Abdominal Aortic Aneurysm

Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.

View on ClinicalTrials.gov

Summary

The objective of this clinical investigational study is to evaluate the safety and efficacy of the Ankura™ II AAA, AE Stent Graft System and the large-size Ankura™ II IE Stent Graft System (i.e., IE stent grafts with distal diameters of 24, 26, and 28 mm) for endovascular treatment of abdominal aortic aneurysm in patients with infrarenal abdominal aortic aneurysm who are suitable for endovascular intervention. The primary safety endpoint is the incidence of major adverse events within 30 days after the procedure. The primary efficacy endpoint is the 12-month treatment success rate.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2026-09-30

Completion Date

2033-06-30

Last Updated

2026-08-12

Healthy Volunteers

No

Interventions

DEVICE

Ankura™ II Abdominal Aortic Stent Graft System

The Ankura™ II Abdominal Aortic Stent Graft System consists of preloaded stent grafts and dedicated delivery systems. The system includes abdominal aortic aneurysm (AAA) stent grafts, iliac artery extension (IE) stent grafts, and aortic extension (AE) stent grafts, each with its corresponding delivery system.

Locations (1)

MBAL Heart and Brain EAD

Pleven, Bulgaria