Patient Preference for Radial Versus Femoral Vascular Access

Coronary Artery Disease Clinical Trial

— PREVAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02625493
• Other study ID #: Prevas-v2
• Status: Completed
• Phase: N/A
• First received: November 30, 2015
• Last updated: February 2, 2017
• Start date: June 2014
• Est. completion date: October 2015

Study information

• Verified date: February 2017
• Source: Thorax Centrum Twente
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: October 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• Questionnaire
Questionnaire containing a Best-worst Scaling scenario

Locations

Country	Name	City	State
Netherlands	Medisch Spectrum Twente	Enschede

Sponsors (2)

Lead Sponsor	Collaborator
Thorax Centrum Twente	Cardio Research Enschede BV

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of times that patients prefer transradial in future percutaneous coronary procedure, when given a discrete choice via a questionnaire.	When given the discrete choice, which access site patients would prefer in future percutaneous coronary procedures.	30 days
Other	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.	The valuation of participation in decision-making on the choice of vascular access together with the interventional cardiologist	30 days
Primary	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