NCT02625493

Brief Summary

The purpose of this study is to determine the preference of patients regarding the vascular access site in future coronary procedures. We hypothesize that patients prefer the lesser invasive procedure via radial access.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
198

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2014

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

June 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 9, 2015

Completed
Last Updated

February 3, 2017

Status Verified

February 1, 2017

Enrollment Period

2 months

First QC Date

November 30, 2015

Last Update Submit

February 2, 2017

Conditions

Keywords

Percutaneous coronary interventionPatient PreferenceRadial accessFemoral accessCoronary angiographyShared decision making

Outcome Measures

Primary Outcomes (1)

  • The best and worst treatment characteristics of transradial and transfemoral access, by using a software-generated Best-Worst Scaling Questionnaire - case 2

    Best-Worst Scaling Questionnaire will be used to assess which treatment characteristics patients find most and least desirable in percutaneous coronary procedures performed via transradial and transfemoral access.

    30 days

Other Outcomes (2)

  • Number of times that patients prefer transradial in future percutaneous coronary procedure, when given a discrete choice via a questionnaire.

    30 days

  • Percentage of patients that wants to be directly involved in the decision-making process when making the choice for access site in future coronary procedures, by use of a questionnaire.

    30 days

Study Arms (1)

study population

All patients who underwent elective coronary procedures belonged to the one group, they received standard care without any additional interventions, but were asked to fill in a questionnaire.

Other: Questionnaire

Interventions

Questionnaire containing a Best-worst Scaling scenario

study population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A consecutive series of patients, who between June and August 2014, underwent elective coronary procedures at Thoraxcentrum Twente in Enschede.

You may qualify if:

  • All patients who undergoing an elective coronary procedure at Thoraxcenteum Twente in the period of June 2014 until August 2014

You may not qualify if:

  • Language barrier

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medisch Spectrum Twente

Enschede, Netherlands

Location

Related Publications (1)

  • Kok MM, Weernink MGM, von Birgelen C, Fens A, van der Heijden LC, van Til JA. Patient preference for radial versus femoral vascular access for elective coronary procedures: The PREVAS study. Catheter Cardiovasc Interv. 2018 Jan 1;91(1):17-24. doi: 10.1002/ccd.27039. Epub 2017 May 4.

MeSH Terms

Conditions

Coronary Artery DiseasePatient Preference

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPatient SatisfactionTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Harald Verheij

    research manager

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 30, 2015

First Posted

December 9, 2015

Study Start

June 1, 2014

Primary Completion

August 1, 2014

Study Completion

October 1, 2015

Last Updated

February 3, 2017

Record last verified: 2017-02

Locations