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Completed

NCT Number: NCT02625493

Patient Preference for Radial Versus Femoral Vascular Access

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medisch Spectrum Twente

Enschede, Netherlands

About this study

Rationale: To explore patient preference for vascular access site in percutaneous coronary procedures, by assessing the perceived importance of benefits and risks of both transradial access and transfemoral access. In addition, direct preference for vascular access and preference for shared decision-making were evaluated.

Objective: To investigate the patient preference of vascular access -transradial versus transfemoral- in future percutaneous coronary procedures, by use of the Best-Worst Scaling.

Study design: Single-center, prospective, observational registry

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

Intervention: All subjects will receive a questionnaire containing basic baseline questions and a best-worst scaling scenario in which they were asked to indicate the most and least desirable characteristics of the vascular access approach.

Furthermore, their direct preference was asked and to which extent they preferred to participate in the decision-making process regarding the choice for vascular access route in future percutaneous coronary procedures.

Main study endpoints:

  • The primary endpoint is the patient preference on specific treatment characteristics with regard to vascular access in coronary procedures.
  • Secondary endpoints include
  • direct patient preference for transradial access or transfemoral access
  • the valuation of participation in decision-making on the choice of vascular access together with the interventional cardiologist.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Language barrier

Treatment and study plan

Questionnaire

Other

Questionnaire containing a Best-worst Scaling scenario

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

    Time frame: 30 days

    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.

Other outcomes

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

    Time frame: 30 days

    When given the discrete choice, which access site patients would prefer in future percutaneous coronary procedures.

  2. 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.

    Time frame: 30 days

    The valuation of participation in decision-making on the choice of vascular access together with the interventional cardiologist

Sponsors and collaborators

Lead sponsor

Thorax Centrum Twente

Other

Collaborators

  • Foundation of Cardiovascular Research and Education Enschede

Registry information

Official study title

Patient Preferences for Radial Versus Femoral Vascular Access Options by Coronary Angiography and Intervention

Acronym: PREVAS

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Dec 9, 2015
Registry last updated
Feb 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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