Phase
Condition
Aneurysm
Treatment
Ankura™ TAA Stent Graft Systems
Ankura™ TAA Stent Graft System
Clinical Study ID
Ages 18-85 All Genders
Study Summary
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:
- 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.
- 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
Connect with a study center
Hospital Espanol de Mendoza
Mendoza,
ArgentinaSite Not Available
RHÖN-KLINIKUM Campus Bad Neustadt
Bad Neustadt An Der Saale,
GermanySite Not Available
Asklepios Klinik Nord Heidberg
Hamburg,
GermanyActive - Recruiting
St. Franziskus Hospital Münster
Muenster,
GermanyActive - Recruiting
LMU Klinikum
Munich,
GermanySite Not Available
Evaggelismos General Hospital
Athens,
GreeceActive - Recruiting
General Hospital of Athens - Georgios Gennimatas
Athens,
GreeceActive - Recruiting
University General Hospital - Attikon
Athens,
GreeceSite Not Available
University General Hospital - Attikon
Attikí,
GreeceActive - Recruiting
Hospital S. Martino
Genova,
ItalySite Not Available
A.O. Ordine Mauriziano di Torino
Turin,
ItalyActive - Recruiting
Hospital Mauriziano
Turin,
ItalySite Not Available
Federal State Budgetary Institution - V.A. Almazov National Medical Research Centre
Saint Petersburg,
Russian FederationActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.