NCT03469388

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 11, 2020

Status Verified

March 1, 2020

Enrollment Period

2.3 years

First QC Date

March 5, 2018

Last Update Submit

March 10, 2020

Conditions

Infrarenal Abdominal Aortic Aneurysm

Keywords

EVAR, central pressure, arterial stiffness, AAA, elective surgery

Outcome Measures

Primary Outcomes (1)

  • central blood pressure

    comparison of invasively recorded and non-invsively estimated central blood pressure

    one week

Secondary Outcomes (3)

  • changes in arterial stiffness pre- and post EVAR

    1 year

  • influence of thrombus on arterial stiffness

    1 year

  • changes in arterial stiffness over time

    1 year

Study Arms (1)

elective EVAR patients

EXPERIMENTAL

Elective EVAR patients will be included in one arm only

Diagnostic Test: Pulse wave analyses; central blood presaure parameters

Interventions

Pulse wave analyses; central blood presaure parametersDIAGNOSTIC_TEST

Pulse wave analyses; central blood presaure parameters

Also known as: Pulse wave velocity
elective EVAR patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female at least 18 years old;
  • Informed consent form understood and signed and patient agrees to follow-up visits;
  • Have a infrarenal abdominal aortic aneurysm (AAA) with maximum sac diameter ≥ 5.5cm, or an AAA ≥ 4.5 cm which has increased by \> 1.0 cm in the past year with a scheduled endovascular intervention

You may not qualify if:

  • Life expectancy \< 2 years;
  • Psychiatric or other condition that may interfere with the study;
  • Participating in another clinical study, interfering on outcomes;
  • Irregular pulse;
  • Presence of extensive peripheral arterial disease (ABI \< 0.9 or obstruction validated on imaging); dated less than 3 months prior to treatment
  • Ruptured, leaking or mycotic aneurysm;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rijnstate Hospital

Arnhem, Gelderland, 6800 TA, Netherlands

Location

Related Publications (1)

  • Holewijn S, Vermeulen JJM, van Helvert M, van de Velde L, Reijnen MMPJ. Validation of Central Pressure Estimation in Patients with an Aortic Aneurysm Before and After Endovascular Repair. Cardiovasc Eng Technol. 2022 Apr;13(2):265-278. doi: 10.1007/s13239-021-00574-3. Epub 2021 Sep 28.

    PMID: 34585343DERIVED

MeSH Terms

Interventions

Pulse Wave Analysis

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Michel Reijnen, MD, PhD

    Rijnstate

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: prospective,multidisciplinary single center study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 5, 2018

First Posted

March 19, 2018

Study Start

April 24, 2017

Primary Completion

August 5, 2019

Study Completion

December 31, 2019

Last Updated

March 11, 2020

Record last verified: 2020-03

Locations

NL(1)