Patient Preference for Radial Versus Femoral Vascular Access

Completed

• Conditions: Coronary Artery Disease
• Interventions: Other: Questionnaire

• Registration Number: NCT02625493
• Lead Sponsor: Thorax Centrum Twente

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.

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2014-08
• Study Completion: 2015-10
• Study First Submitted: 2015-11-30
• Study First Submitted QC: 2015-12-04
• Study First Posted: 2015-12-09
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
study population	Questionnaire	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Medisch Spectrum Twente; 🇳🇱 Enschede, Netherlands