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

Last updated: June 5, 2024
Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aneurysm

Treatment

Ankura™ TAA Stent Graft Systems

Ankura™ TAA Stent Graft System

Clinical Study ID

NCT05639569
LT/TS/12C-2021-01
  • Ages 18-85
  • All Genders

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).

Eligibility Criteria

Inclusion

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 clinicaltrial, agrees to its provisions, agrees to comply with the requirements of the studyincluding a 3-year follow-up, and signed applicable Informed Consent Form.

  • Patient's characteristics consistent with Ankura™ Stent Graft System IFU and sizingguidelines, which indicate as following:

  1. For descending thoracic aortic aneurysm (DTA) patient:
  • Adequate iliac/femoral access vessel that is compatible with the requireddelivery 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.
  1. For type B aortic dissection (TBAD) patient:
  • Adequate iliac/femoral access vessel that is compatible with the requireddelivery system.
  • ≥15mm landing zone proximal to the primary entry tear; proximal extent ofthe landing zone must not be dissected. Diameter at proximal extent ofproximal landing zone in the range of 16-44mm.
  • ≥15mm landing zone distal to the primary entry tear; distal extent of thelanding zone must not be dissected. Diameter at distal extent of distallanding zone in the range of 16-44mm.
  • Morphology suitable for endovascular repair.

Exclusion

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 mesentericartery;

  • 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 Bdissections, 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 toMarfan Syndrome or Ehlers-Danlos Syndrome;

  • Patient with morbid obesity, weight greater than 350 Pounds (150kg), or who cannotundergo 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 HeartAssociation 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 thatwould lead to failure of introduction and advancing an introducer sheath;

  • Any condition (medical or anatomic) which makes the patient not suitable forendovascular repair according to the opinion of the investigator.

Study Design

Total Participants: 145
Treatment Group(s): 2
Primary Treatment: Ankura™ TAA Stent Graft Systems
Phase:
Study Start date:
May 03, 2023
Estimated Completion Date:
December 30, 2030

Connect with a study center

  • Hospital Espanol de Mendoza

    Mendoza,
    Argentina

    Site Not Available

  • RHÖN-KLINIKUM Campus Bad Neustadt

    Bad Neustadt An Der Saale,
    Germany

    Site Not Available

  • Asklepios Klinik Nord Heidberg

    Hamburg,
    Germany

    Active - Recruiting

  • St. Franziskus Hospital Münster

    Muenster,
    Germany

    Active - Recruiting

  • LMU Klinikum

    Munich,
    Germany

    Site Not Available

  • Evaggelismos General Hospital

    Athens,
    Greece

    Active - Recruiting

  • General Hospital of Athens - Georgios Gennimatas

    Athens,
    Greece

    Active - Recruiting

  • University General Hospital - Attikon

    Athens,
    Greece

    Site Not Available

  • University General Hospital - Attikon

    Attikí,
    Greece

    Active - Recruiting

  • Hospital S. Martino

    Genova,
    Italy

    Site Not Available

  • A.O. Ordine Mauriziano di Torino

    Turin,
    Italy

    Active - Recruiting

  • Hospital Mauriziano

    Turin,
    Italy

    Site Not Available

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

    Saint Petersburg,
    Russian Federation

    Active - Recruiting

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