The Effect of Targeted Pre- and Post-operative Blood Pressure Control on the Incidence of Type II Endoleak post-Endovascular Aneurysm Repair (EVAR): A Prospective, Randomised, Controlled Trial

Vascular Surgery Department, Royal Brisbane and Women's Hospital0 个研究点目标入组 100 人开始时间: 2020年5月29日最近更新: 2020年6月8日

适应症

试验速览

暂无简介。

•>50-yers of age
•Infrarenal abdominal aortic aneurysm >50mm, including asymptomatic and inflammatory aneurysms; for Endovascular aneurysm repair (EVAR)

•EVAR for ruptured or symptomatic aneurysms
•<50-years of age
•Known secondary cause of hypertension that causes concern regarding safety of the protocol; including end-stage renal disease (ESRF), any organ transplant in the 3-months before enrolment
•Orthostatic hypotension
•oDefined as: one-minute standing SBP <110mmHg at the enrolment appointment
•End-stage medical condition with a prognosis <12-months
•Recent cardiovascular event (e.g myocardial infarction) and/or recent emergency cardiovascular procedure (incl. percutaneous coronary intervention, CABG)
•Current diagnosis of congestive cardiac failure (CCF)
•oDefined as; New York Heart Association (NYHA) Class 3-4 symptoms OR echocardiogram-estimate of Left Ventricular Ejection Fraction <30% OR Cardiologist-determined diagnosis of CCF
•Arm circumference that prohibits consistent and accurate blood pressure measurement
•Participation in another interventional clinical study
•Documented cognitive impairment, including a diagnosis of dementia AND/OR active or recent excessive alcohol/substance use <3-months prior to enrolment
•Secondary exclusion criteria apply AFTER surgery:
•EVAR stent-grafted not used to the manufacturer’s Instructions For Use (IFU)
•Ongoing presence of a Type Ia/Ib, III or IV endoleak noted at the time of completion angiography; thereby not excluding treated leaks

发起方

Vascular Surgery Department, Royal Brisbane and Women's Hospital