Post-Market Clinical Follow-Up (PMCF) Study Plan -BeGraft Aortic Stent Graft System

Bentley InnoMed GmbH0 个研究点目标入组 73 人开始时间: 2018年2月8日最近更新: 2024年8月19日

适应症

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•The BeGraft Aortic Stent Graft System” is indicated for - the implantation in the native and/or recurrent coarctation of the aorta (CoA*) on adolescent or adult patients with the following clinical conditions:
•-- Stenosis of the aorta resulting in significant anatomic narrowing as determined by angiography or noninvasive imaging, i.e. echocardiography, magnetic resonance imaging (MRI), CT scan;
•-- Stenosis of the aorta resulting in hemodynamic alterations, resulting in systolic pressure gradient, systemic hypertension or altered left ventricular function;
•-- Stenosis of the aorta where balloon angioplasty is ineffective or contraindicated;
•-- Stenosis diameter <20% of the adjacent vessel diameter. Stenosis that would present increased risk of vascular damage of disruption.
•- and furthermore for restoring and improving the patency of the iliac arteries.

•1. When PTA is technically not possible (e. g. not feasible to access the lesion with guide wire or balloon catheter)
•2. Patients too small to allow safe delivery of the Stent Graft without compromise to the systemic artery used for delivery
•3. Clinical or biological signs of infection
•4. Active endocarditis
•5. Known allergy to aspirin, other antiplatelet agents, or heparin
•6. Pregnancy
•7. Aneurysms immediately adjacent to the site of Stent Graft implantation
•8. Stenosis distal to the site of Stent Graft implantation
•9. Lesions in or adjacent to essential collateral(s)
•10. Lesions in locations subject to external compression
•11. Heavily calcified lesions resistant to PTA
•12. Patients with diffuse distal disease resulting in poor Stent Graft outflow
•13. Patients with a history of coagulation disorders
•14. Patients with aspirin allergy or bleeding complications and patients unable or unwilling to tolerate anticoagulant / antiplatelet therapy and / or non-responders to anticoagulant / antiplatelet therapy
•15. Fresh thrombus formation
•16. Patients with known hypersensitivity to the stent material (cobalt-chromium (L605)) and / or ePTFE

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