BGP+ Stent as Bridging Stent in BEVAR

Who can take part

• Patient eligible for elective repair of TAAA with BEVAR in accordance with the applicable guidelines for vascular interventions (e.g. Aneurysm size 6cm or aneurysm growth of >5mm within 6 months or 1cm within 1 year)
• Patient is willing to comply with specified follow-up evaluations at the specified times
• Patient is >55 years old
• Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the trial; Patient has a projected life-expectancy of at least 12-months
• Patient needs to have a landing zone in their target vessel of at least 15 mm, and coverage/ wall adaptation of the BGP+ should be obtained for at least 10 mm
• The access vessel for introduction of the sheath through which the BGP+ will be advanced should be at least 3mm (it should be able to fit a 8F sheath)
• No early important division branch from the target vessel with risk of coverage
• Absence of pre-existing dissection in the target vessels
• Target vessels (renal arteries, superior mesenteric artery, and celiac trunk) for the BGP+ must have a diameter between 5 and 10 mm
• Aortic endoprosthesis with inner branches (can be hybrid or branches only)
• Hybrid aortic endoprosthesis with fenestrations and branches (at least 2 and only the target vessels which are connected by a branch shall be treated with a study device within this study)
• At least one target vessel is bridged with only one BGP+ (relining allowed)
• Full compliance with all inclusion criteria/exclusion criteria and all intraoperative criteria

Who cannot take part

• Previously implanted stent in the target vessel
• Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
• Any planned surgical intervention/procedure within 30 days of the trial procedure
• Patient is currently participating in another conflicting investigational drug or device trial that has not completed the entire follow up period
• Hybrid Approach (endovascular in combination with open surgery)
• Myocardial infarction or stroke within 3 months prior to the procedure
• Patients with uncorrected bleeding disorders or heparin induced thrombocytopenia
• Patients with diffuse distal disease resulting in poor stent outflow
• Patients with known hypersensitivity to the stent material (L605) and/or PTFE
• Patients with a connective tissue disorder
• Patients with an unstable angina pectoris or heart insufficiency NYHA 3 or 4
• Patients with access vessel which are too tortuous, narrow or any kind of reason that would lead to failure of introducing and advancing an introducer sheath
• Renal artery with >100° cranial orientation
• Patients refusing treatment
• Female patient with childbearing potential not taking adequate contraceptives or currently breastfeeding
• Patients with rupture or any patient considered to be hemodynamically unstable at onset of procedure
• Fresh thrombus formation within the last 14 days
• Patients with mycotic or inflammatory aneurysm
• Patients with ASA classification 5 or higher
• Contraindications against contrast enhanced angiography (a.e. massive hyperthyroidism)
• Patients with increased risk of intraoperative rupture