NCT05639569

Ankura™ TAA Stent Graft System Post-Market Clinical Follow-up Study

Ankura™ TAA Stent Graft System Post-Market Clinical Follow-up Study: Multi-center, Prospective, Observational, Post-Market Follow-up Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 145 (estimated)
• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to collect clinical data on patient outcomes, evaluate the safety and performance of Ankura TAA Stent Graft System and Surpass Super Stiff Guidewire, and build clinical evidence for patients with Descending Thoracic Aneurysm (DTA) or Type B Aortic Dissection (TBAD).

Detailed description

The physician shall strictly follow the clinical study protocol and shall not deviate from or substantially change the protocol. However, in case of emergency such as immediate risk to the subjects, which needs tobe eliminated immediately, it may be reported in written form afterwards. During the course of the study,documents such as amendments to the clinical study protocol and informed consent, requests for deviation,and resumption of the suspended clinical study shall be subject to the written approval of the Ethics Committee

Conditions

• Aneurysm Thoracic
• Dissection of Thoracic Aorta

Interventions

Type	Name	Description
DEVICE	Ankura™ TAA Stent Graft System	All patients will be implanted with Ankura™ TAA Stent Graft System in accordance with the instructions for use (IFU).

Timeline

• Start date: 2023-05-03
• Primary completion: 2026-12-30
• Completion: 2030-12-30
• First posted: 2022-12-06
• Last updated: 2025-06-22

Locations

8 sites across 4 countries: Germany, Greece, Italy, Russia