Coronary Artery DiseasePREVASNCT02625493
Patient Preference for Radial Versus Femoral Vascular Access
An observational study of Coronary Artery Disease, run by Thorax Centrum Twente at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Questionnaire
- How many people
- 198 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2014to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A consecutive series of patients, who between June and August 2014, underwent elective coronary procedures at Thoraxcentrum Twente in Enschede.
Who may be able to join
- All patients who undergoing an elective coronary procedure at Thoraxcenteum Twente in the period of June 2014 until August 2014
Who cannot join
- Language barrier
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Preferences for Radial Versus Femoral Vascular Access Options by Coronary Angiography and Intervention
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.
Read the 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
- 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Questionnaire
- Keywords
- Percutaneous coronary intervention, Patient Preference, Radial access, Femoral access, Coronary angiography, Shared decision making
- Medical subject headings
- Coronary Artery Disease, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaire containing a Best-worst Scaling scenario
| Study group | Role | What they receive |
|---|---|---|
| study population | 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. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study startJun 2014
- Primary completionAug 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thorax Centrum Twente
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation of Cardiovascular Research and Education Enschede
- Responsible party
- Principal investigator, Clemens von Birgelen, Thorax Centrum Twente
- Investigators
- Harald Verheij, Study director, research manager
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625493
- Sponsor's protocol ID
- Prevas-v2
- Acronym
- PREVAS
- Status last verified
- Feb 2017
- First submitted
- 30 Nov 2015
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28470994
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Preferences for Radial Versus Femoral Vascular Access Options by Coronary Angiography and Intervention
- ClinicalTrials.gov ID
- NCT02625493
- Acronym / sponsor ID
- PREVAS / Prevas-v2
- Conditions
- Coronary Artery Disease
- Keywords
- Percutaneous coronary intervention, Patient Preference, Radial access, Femoral access, Coronary angiography, Shared decision making
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Thorax Centrum TwenteUniversity, hospital or other
- Collaborators
- Foundation of Cardiovascular Research and Education Enschede
- Study start
- Jun 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 9 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study population | – | Other: QuestionnaireAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A consecutive series of patients, who between June and August 2014, underwent elective coronary procedures at Thoraxcentrum Twente in Enschede.
Key inclusion criteria (1 listed)
- All patients who undergoing an elective coronary procedure at Thoraxcenteum Twente in the period of June 2014 until August 2014
Key exclusion criteria (1 listed)
- Language barrier
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireQuestionnaire containing a Best-worst Scaling scenario | Other | study population |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
- Derived from this study: PubMed 28470994Kok 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harald Verheij study director
research manager
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Thorax Centrum Twente at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02625493, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2017.