The Effect of Pre- and Post-Operative Blood Pressure Control on the Incidence of Type II Endoleak after Endovascular Aneurysm Repair (BOLD Trial)

Not Applicable

• Conditions: Endoleak; Hypertension; Surgery - Surgical techniques; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12620000632998
• Lead Sponsor: Vascular Surgery Department, Royal Brisbane and Women's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-29
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified