Ignite Creation Date:
2024-05-06 @ 11:14 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03469388
Status:
COMPLETED
Last Update Posted:
2020-03-11
First Post:
2018-03-05
Brief Title:
Arterial Stiffness Blood Pressure and Cardiac Output Study
Sponsor:
Rijnstate Hospital
Organization:
Rijnstate Hospital
Study Overview
Official Title:
Arterial Stiffness Blood Pressure and Cardiac Output Study ABC-study A Prospective Multidisciplinary Study of Arterial Stiffness Measures in Patients Treated for Aortic Aneurysms in Relation to Blood Pressure and Cardiac Output
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ABC
Brief Summary:
Comparison of non-invasively obtained central blood pressure using SphygmoCor and invasively recorded central blood pressure in patients with an AAA that will be treated with EVAR
Detailed Description:
Primary objective of the first study validation of non-invasive central pressure parameters in patients treated with EVAR against invasive measurements
Objectives of subsequent studies Do non-invasive central parameters change over time after EVAR What is the influence of intraluminal thrombus presence amount configuration on non-invasive central pressure parameters and other obtained parameters of arterial stiffness Prospective study with consecutive eligible subject enrollment All subjects will undergo the Endovascular Aneurysm repair procedure with an endovascular device Subjects will be followed procedurally at 6-8 weeks and 1 year post implantation
This study is a collaboration of the following departments of the Vascular Center in the Rijnstate Hospital Arnhem Vascular Surgery Interventional radiology Internal Vascular Medicine Cardiology
Patients diagnosed with an abdominal aortic or aortoiliac aneurysm who are considered candidates for endovascular repair and who meet the study eligibility criteria may be screened for enrollment in the study Up to 20 subjects will be enrolled
Pre-procedural high resolution contrast-enhanced CT scan evaluation to determine anatomical eligibility for enrollment will be performed within three months of the study procedure according to standard care Following ECIRB approval of the study and the written informed consent form patients will be screened for eligibility Following informed consent clinical characteristics will be reported from hospital records Per-procedural PWA measurements will be performed simultaneously with intravascular pressure measurements pre-implantation and after completion of the endocasular implantation Subjects will be followed at 30 days and 1 year post-implantation
Objectives of subsequent studies Do non-invasive central parameters change over time after EVAR What is the influence of intraluminal thrombus presence amount configuration on non-invasive central pressure parameters and other obtained parameters of arterial stiffness Prospective study with consecutive eligible subject enrollment All subjects will undergo the Endovascular Aneurysm repair procedure with an endovascular device Subjects will be followed procedurally at 6-8 weeks and 1 year post implantation
This study is a collaboration of the following departments of the Vascular Center in the Rijnstate Hospital Arnhem Vascular Surgery Interventional radiology Internal Vascular Medicine Cardiology
Patients diagnosed with an abdominal aortic or aortoiliac aneurysm who are considered candidates for endovascular repair and who meet the study eligibility criteria may be screened for enrollment in the study Up to 20 subjects will be enrolled
Pre-procedural high resolution contrast-enhanced CT scan evaluation to determine anatomical eligibility for enrollment will be performed within three months of the study procedure according to standard care Following ECIRB approval of the study and the written informed consent form patients will be screened for eligibility Following informed consent clinical characteristics will be reported from hospital records Per-procedural PWA measurements will be performed simultaneously with intravascular pressure measurements pre-implantation and after completion of the endocasular implantation Subjects will be followed at 30 days and 1 year post-implantation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NL5715309116 | OTHER | CMO-Arnhem Nijmegen | None |