Femoral Artery AccessNCT00638586
Comparison of Patients Undergoing Radial or Femoral Arterial Access for Percutaneous Catheterization-Nursing Aspects
An observational study of Femoral Artery Access and Radial Artery Access, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Transradial access is a recently developed alternative for diagnostic andf interventional cardiac catheterization. We sought to compare the differences between patients that have undergone PTCA transradial and transfemoral access from the nursing point of view: 1. Anxiety levels 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoral Artery Access, Radial Artery Access
- How many people
- 160 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2008to not given
- 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: All hospitalized patients that are candidates for undergoing PTCA.
Who may be able to join
- All patients scheduled for PTCA without any exclusion criteria
Who cannot join
- Dementia
- Psychiatric patients
- Unconscious
- Minors
- Patients who had PTCA in past
- Patients who were initially scheduled for different access
Trial locations and contacts
1 site in 1 country.
About this study
Transradial access is a recently developed alternative for diagnostic andf interventional cardiac catheterization. We sought to compare the differences between patients that have undergone PTCA transradial and transfemoral access from the nursing point of view:
- Anxiety levels
- Pain at access point, pain in general and level of pain during mobility
- Differences in feelings of embarrassement
- Differences in satisfaction
- Conditions
- Femoral Artery Access, Radial Artery Access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Femoral access | |
| 2 | Radial access |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study startApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Artery AccessStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00638586
- Sponsor's protocol ID
- HY/102008
- Status last verified
- Mar 2008
- First submitted
- 12 Mar 2008
- Last updated
- 19 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Patients Undergoing Radial or Femoral Arterial Access for Percutaneous Catheterization-Nursing Aspects
- ClinicalTrials.gov ID
- NCT00638586
- Acronym / sponsor ID
- HY/102008
- Conditions
- Femoral Artery Access, Radial Artery Access
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Apr 2008
- First posted
- 19 Mar 2008 (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.
Transradial access is a recently developed alternative for diagnostic andf interventional cardiac catheterization. We sought to compare the differences between patients that have undergone PTCA transradial and transfemoral access from the nursing point of view:
- Anxiety levels
- Pain at access point, pain in general and level of pain during mobility
- Differences in feelings of embarrassement
- Differences in satisfaction
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Femoral access |
| 2 | – | –Radial access |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All hospitalized patients that are candidates for undergoing PTCA.
Key inclusion criteria (1 listed)
- All patients scheduled for PTCA without any exclusion criteria
Key exclusion criteria (6 listed)
- Dementia
- Psychiatric patients
- Unconscious
- Minors
- Patients who had PTCA in past
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Femoral Artery Access and Radial Artery Access, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 6 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: status not confirmed, as of the sponsor's last update on 19 Mar 2008. 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 Israel. 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?
Results are not available in the source record.
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.
Where can I read the original study information?
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 19 Mar 2008.