Prospective, Multicenter, Single Arm Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System for the Endovascular Repair of Juxtarenal/Pararenal (JAA/PAA) Aneurysms - Ventana Study

Endologix Inc.0 个研究点目标入组 5 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•Male or female at least 18 years old; informed consent understood and signed and patient agrees to all follow-up visits; have aortic aneurysm with maximum diameter *5.5cm, or between 4.5 and 5.5cm and rapidly expanding (>0.5cm in six months), or >50% larger than normal aortic diameter. Anatomically eligible for the Endologix Bifurcated System per the FDAapproved indications for use (IFU) and for the Fenestrated Stent Graft System.

•Life expectancy <2 years as judged by the investigator; Psychiatric or other condition that may interfere with the study; Participating in the enrollment or 30-day follow-up phase of another clinical study; Known allergy to any device component; Coagulopathy or uncontrolled bleeding disorder; Contraindication to contrast media or anticoagulants; Ruptured, leaking, or mycotic aneurysm; Aortic dissection Serum creatinine (S-Cr) level >2.0 mg/dL;Traumatic vascular injury; Active systemic or localized groin infection; Connective tissue disease (e.g., Marfan*s Syndrome);
•Recent (within prior three months) cerebrovascular accident or myocardial infarction; Prior renal transplant; Length of either renal artery to be stented <12mm; Significant occlusive disease of either renal artery (>70%); An essential accessory renal artery; Indispensable inferior mesenteric artery; Untreated aneurysmal disease of the descending thoracic aorta; Prior iliac artery stent implanted that may interfere with delivery system introduction; Unsuitable vascular anatomy; Pregnancy (female patient of childbearing potential only).

发起方