ClinicalTrials.gg
Active, not recruitingNCT05639569Updated May 26, 2026

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

An observational study in Aneurysm Thoracic and Dissection of Thoracic Aorta, sponsored by Lifetech Scientific (Shenzhen) Co., Ltd.. Active, not recruiting at 15 sites in 5 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-05-26.

Sponsored by Lifetech Scientific (Shenzhen) Co., Ltd. (part of LifeTech Scientific Corporation) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
147
Ages
18 Years to 85 Years
Sex
All
01

Study 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).

Read the 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

02

Conditions studied

  • Aneurysm Thoracic
  • Dissection of Thoracic Aorta
03

In context

Aortic Aneurysm, Thoracic

131 studies on the registry are indexed under Aortic Aneurysm, Thoracic; 33 are open to participants now.

This study's enrollment of 147 is close to the median of 154 across 65 observational studies indexed under Aortic Aneurysm, Thoracic.

Browse Aortic Aneurysm, Thoracic studies →

Lead sponsor

Lifetech Scientific (Shenzhen) Co., Ltd. is the lead sponsor of 44 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient has descending thoracic aortic aneurysm (DTA) or type B aortic dissection (TBAD), who needs endovascular repair (TEVAR).
  • > 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 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

Exclusion Criteria:

  • Patient with any 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;
  • Physical Status Classification (ASA) classification 5 or higher;
  • Patient with an unstable angina pectoris or hearth insufficiency 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
147 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • DeviceAnkura™ TAA Stent Graft System

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

06

What researchers measure

Primary outcomes

  1. Incidence of major adverse events

    Incidence of major adverse events.

    Time frame: Timeframe: within 30-day post-implantation

  2. Freedom from stent graft-related events

    Freedom from stent graft-related events (12 months)

    Time frame: Timeframe: within 12-month post-implantation

07

Study locations

15 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05639569
Responsible party
Sponsor
First posted
Dec 6, 2022
Start date
May 3, 2023
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2030 (estimated)
Last update
May 26, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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