Clinical trial NCT02625493: Patient Preference for Radial Versus Femoral Vascular Access
Official title: Patient Preferences for Radial Versus Femoral Vascular Access Options by Coronary Angiography and Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Percutaneous coronary intervention
Patient Preference
Radial access
Femoral access
Coronary angiography
Shared decision making
Lead sponsor: Thorax Centrum Twente
Sponsor class: OTHER
Collaborators: name: Foundation of Cardiovascular Research and Education Enschede
First posted: 2015-12-09
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A consecutive series of patients, who between June and August 2014, underwent elective coronary procedures at Thoraxcentrum Twente in Enschede.

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.

Detailed description: 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

  1. direct patient preference for transradial access or transfemoral access
  2. the valuation of participation in decision-making on the choice of vascular access together with the interventional cardiologist.

Eligibility criteria: 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

Primary outcomes:
measure: The best and worst treatment characteristics of transradial and transfemoral access, by using a software-generated Best-Worst Scaling Questionnaire - case 2
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
measure: Number of times that patients prefer transradial in future percutaneous coronary procedure, when given a discrete choice via a questionnaire.
timeFrame: 30 days
measure: 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.
timeFrame: 30 days
Locations:
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
Study officials:
affiliation: research manager
name: Harald Verheij
role: STUDY_DIRECTOR
References:
citation: 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.