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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Aneurysm Thoracic; Dissection of Thoracic Aorta
• Intervention / Treatment: Device: Ankura™ TAA Stent Graft System

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

• Study Type: Observational
• Enrollment (Actual): 147

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany
    • Asklepios Klinik Nord Heidberg
  • Münster, Germany
    • St. Franziskus Hospital Münster
• Greece
  • Athens, Greece
    • Evaggelismos General Hospital
  • Athens, Greece
    • General Hospital of Athens - Georgios Gennimatas
  • Attiki, Greece
    • University General Hospital - Attikon
• Italy
  • Turin, Italy
    • A.O. Ordine Mauriziano di Torino
• Russia
  • Moscow, Russia
    • Petrovsky National Research Centre of Surgery
  • Saint Petersburg, Russia
    • Federal State Budgetary Institution - V.A. Almazov National Medical Research Centre
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye)
    • Ankara Etlik City Hospital
  • Ankara, Turkey (Türkiye)
    • Ankara Bilkent City Hospital
  • Ankara, Turkey (Türkiye)
    • Ankara University Hospital Heart Center
  • Erzurum, Turkey (Türkiye)
    • Erzurum University Hospital
  • Eskişehir, Turkey (Türkiye)
    • Eskişehir City Hospital
  • Gaziantep, Turkey (Türkiye)
    • Gaziantep City Hospital
  • Izmir, Turkey (Türkiye)
    • Izmir City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with Descending Thoracic Aneurysm (DTA) or Type B Aortic Dissection (TBAD) and indicate for endovascular repair (TEVAR).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of major adverse events	Incidence of major adverse events.	Timeframe: within 30-day post-implantation
Freedom from stent graft-related events	Freedom from stent graft-related events (12 months)	Timeframe: within 12-month post-implantation

Collaborators and Investigators

• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
• Investigators: Principal Investigator: Marco Virgilio Usai, Dr, St. Franzsiskus-Hospital GmbH

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2030

Study Registration Dates

• First Submitted: November 26, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 6, 2022

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Dissection; Dissection, Thoracic Aorta; Aortic Aneurysm, Thoracic
• Other Study ID Numbers: LT/TS/12C-2021-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No