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

NCT ID: NCT05639569

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 145 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-03
• Study Completion Date: 2030-12-30

Brief 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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with Descending Thoracic Aneurysm (DTA) or Type B Aortic Dissection (TBAD)

All patients who signed informed consent and are used with Ankura™ TAA Stent Graft Systems will undergo follow-up (FU) evaluations as per local hospital standards and corresponding IFU which is expected to be at the following time points post-implant:

Before discharge, 30days after the procudure, 3-6 months after the Procedure, 12 months after the procedure, 24 months after the procedure, 36 months after the procedure

Ankura™ TAA Stent Graft System

Intervention Type: DEVICE

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

Interventions

Ankura™ TAA Stent Graft System

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient has descending thoracic aortic aneurysm (DTA) or type B aortic dissection (TBAD), who needs endovascular repair (TEVAR).
• Life expectancy > 1 year.
• Patient or legally authorized representative understands the nature of the clinical trial, agrees to its provisions, agrees to comply with the requirements of the study including a 3-year follow-up, and signed applicable Informed Consent Form.
• Patient's characteristics consistent with Ankura™ Stent Graft System IFU and sizing guidelines, which indicate as following:

1. For descending thoracic aortic aneurysm (DTA) patient:

• Adequate iliac/femoral access vessel that is compatible with the required delivery system.
• Aortic inner diameter in the range of 18-42mm.
• ≥15mm non-aneurysmal aorta proximal and distal to the lesion.
• Morphology suitable for endovascular repair.

2. For type B aortic dissection (TBAD) patient:

• Adequate iliac/femoral access vessel that is compatible with the required delivery system.
• ≥15mm landing zone proximal to the primary entry tear; proximal extent of the landing zone must not be dissected. Diameter at proximal extent of proximal landing zone in the range of 16-44mm.
• ≥15mm landing zone distal to the primary entry tear; distal extent of the landing zone must not be dissected. Diameter at distal extent of distal landing zone in the range of 16-44mm.
• Morphology suitable for endovascular repair.

Exclusion Criteria

• Patient with any contraindications mentioned in the Ankura™ Stent Graft System IFU:

• Patients with acute systemic infection;
• Patients who have had other devices implanted in the cardiovascular cavity, which will interfere with the placement of this device;
• Patients with mesenteric blood flow mainly supplied by the inferior mesenteric artery;
• Patients who have allergic reaction to the device;
• Patients who are not suitable for endovascular repair in vascular morphology;
• Patients who cannot tolerate contrast agents due to severe renal insufficiency;
• Patients who are allergic to contrast agents;
• Aneurysms neck with thrombus;
• Non-aneurysmal aortic proximal neck length <1.5cm;
• Non-aneurysmal aortic distal anchorage zone <1.5cm;
• For aneurysms, Non-aneurysmal aortic diameter <18mm or >42mm. For Type B dissections, Non-aneurysmal aortic diameter <16mm or >44mm.
• 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 morbid obesity, weight greater than 350 Pounds (150kg), or who cannot undergo accurate fluoroscopy examination due to obesity;
• Age<18 Years or Age> 85 Years;
• Pregnant or plan to be pregnant or breast feeding;
• Myocardial infarction or stroke within 3 months prior to the procedure;
• American Society of Anesthesiologists Physical Status Classification (ASA) classification 5 or higher;
• Patient with an unstable angina pectoris or hearth insufficiency New York Heart Association Functional Classification (NYHA) 3 or 4
• Participant in other drug or medical device clinical trials;
• Patient with access vessel which are to tortuous, narrow or any kind of reasons that would lead to failure of introduction and advancing an introducer sheath;
• Any condition (medical or anatomic) which makes the patient not suitable for endovascular repair according to the opinion of the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lifetech Scientific (Shenzhen) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

RHÖN-KLINIKUM Campus Bad Neustadt

Bad Neustadt an der Saale, , Germany

Site Status: NOT_YET_RECRUITING

Asklepios Klinik Nord Heidberg

Hamburg, , Germany

Site Status: RECRUITING

St. Franziskus Hospital Münster

Münster, , Germany

Site Status: RECRUITING

Evaggelismos General Hospital

Athens, , Greece

Site Status: RECRUITING

General Hospital of Athens - Georgios Gennimatas

Athens, , Greece

Site Status: RECRUITING

University General Hospital - Attikon

Attiki, , Greece

Site Status: RECRUITING

A.O. Ordine Mauriziano di Torino

Turin, , Italy

Site Status: RECRUITING

Federal State Budgetary Institution - V.A. Almazov National Medical Research Centre

Saint Petersburg, , Russia

Site Status: RECRUITING

Countries

Germany; Greece; Italy; Russia

Central Contacts

Rae Gong

Role: CONTACT

gongrui@lifetechmed.com

+86 18820162460

Facility Contacts

Michael Zacher

Role: primary

Marwan Youssef

Role: primary

Marco Virgilio Usai

Role: primary

Martin Austermann

Role: backup

Theodoros Kratimenos

Role: primary

Vasileios Katsikas

Role: primary

Ioannis Kakisis

Role: primary

Andrea Gaggiano

Role: primary

Mikhail Aleksandrovich Chernyavskiy

Role: primary

Daria Viktorovna Chernova

Role: backup

Other Identifiers

LT/TS/12C-2021-01

Identifier Type: -

Identifier Source: org_study_id