Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-01-05 @ 5:59 PM
Study NCT ID:
NCT02625493
Status:
COMPLETED
Last Update Posted:
2017-02-03
First Post:
2015-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Preference for Radial Versus Femoral Vascular Access
Sponsor:
Thorax Centrum Twente
Organization:
Study Overview
Official Title:
Patient Preferences for Radial Versus Femoral Vascular Access Options by Coronary Angiography and Intervention
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREVAS
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: