Phase
Condition
Aneurysm
Heart Disease
Cardiovascular Disease
Treatment
Ankura™ AAA Stent Graft System; Ankura™ Cuff Stent Graft System; Ankura™ AUI Stent Graft System
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient diagnosed with Abdominal Aortic Aneurysm (AAA), who needs endovascularaortic repair;
Patient's anatomy suits Ankura™ AAA and Cuff Stent Graft Systems, or AUI Stent GraftIFU requirements, which indicated by the following:
Adequate iliac/femoral access vessel that is compatible with the requireddelivery system.
Non-aneurysmal proximal aortic neck length ≥15mm.
Non-aneurysmal proximal aortic neck diameter of 18-32mm.
Proximal aortic neck angulation ≤ 60°.
Distal iliac artery anchorage zone ≥15mm.
Distal iliac artery diameter of i. 8-22 mm (for Ankura™ AAA and Cuff StentGraft Systems), OR ii. 10-16 mm (for Ankura™ AUI Stent Graft System).
Morphology suitable for endovascular repair.
Patient could understand the purpose of the clinical trial, agrees to comply withthe requirements of the study including the 3-year follow-up, and signed the patientinformed consent, will participate in the study.
Exclusion
Exclusion Criteria:
Age<18 years or Age>85 years;
Patients' life expectancy < 1 year;
Pregnant or plan to be pregnant or breast feeding;
Patient with any contraindications mentioned in the Ankura™ AAA and Cuff Stent GraftSystems, or in Ankura™ AUI Stent Graft system IFU:
Patient with acute systemic infection;
Patient with mesenteric blood flow mainly supplied by the inferior mesentericartery;
Patient with accessory renal artery original from abdominal artery;
Patient who has allergic reaction to the device;
Patient who is not suitable for endovascular repair in vascular morphology;
Patient who cannot tolerate contrast agents due to renal insufficiency;
Patient who is allergic to contrast agent;
Patient's aneurysms neck has thrombus;
Non-aneurysmal proximal aortic neck length <15mm;
Non-aneurysmal proximal aortic neck diameter <18mm or >32mm;
Proximal aortic neck angulation > 60°;
Distal iliac artery anchorage zone <15mm;
Distal iliac artery diameter: i. For Ankura™ AAA and Cuff Stent Graft Systems: <8mm or >22mm, OR ii. For Ankura™ AUI Stent Graft system: <10mm or >16mm.
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 concomitant thoracic aortic or thoraco-abdominal aneurysms;
Patient who weighs greater than 350 pounds (150kg) or cannot undergo accuratefluoroscopy examination due to obesity.
Acute myocardial infarction or heart failure (NYHA class III and IV), respiratoryfailure, malignant tumor and other serious systemic diseases.
Subject must not be participating in another study for an investigational drugand/or device that may clinically interfere with this study's endpoints.
Any condition (medical or anatomic) which makes the patient not suitable forendovascular repair according to the opinion of the investigator.
Study Design
Study Description
Connect with a study center
MBAL Heart and Brain EAD
Pleven, 5804
BulgariaSite Not Available
Military Medical Academy
Sofia, 1606
BulgariaActive - Recruiting
National Hospital of Cardiology
Sofia, 1309
BulgariaActive - Recruiting
University Hospital for Active Treatment "Sofiamed"
Sofia, 1797
BulgariaSite Not Available
Laiko - University Hospital of Athens
Athens, 11527
GreeceSite Not Available
General University Hospital of Patras
Patras, 26504
GreeceSite Not Available
Papageorgiou General Hospital
Thessaloniki, 56403
GreeceSite Not Available
Ankara City Hospital
Ankara, 06800
TurkeySite Not Available
Ankara University Heart Center
Ankara, 06340
TurkeySite Not Available
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