Injury of Radial ArteryNCT02017054
Feasibility and Outcomes of Repetitive Radial Approach
An observational study of Injury of Radial Artery, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to assess the feasibility of performing repetitive coronary angiograms via the radial approach Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Injury of Radial Artery
- What is being tested?
- Cath
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2015to Dec 2017
- How long will I take part?
- 1 Month
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with previous history of trans radial cardiac cath who are planned for additional trans radial cardiac cath
Who may be able to join
- Patients with previous successful radial artery approach scheduled for elective transradial coronary angiography
Who cannot join
- Lack of indication to perform radial approach Abnormal Barbeau test result (type C and D) Presence of radial artery occlusion Previous important trauma of the upper limbs Presence of fistula for renal dialysis Lymphoedema Acute myocardial infarction Refusal to sign the informed consent form
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the feasibility of performing repetitive coronary angiograms via the radial approach
Read the detailed description
Assessing succes of radial access in patients with prior TRA procedures
- Conditions
- Injury of Radial Artery
- Being tested
- Cath
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CathOther
Also called No intervention - registry
No intervention - registry
| Study group | Role | What they receive |
|---|---|---|
| Cath patients | Patients with previous cardiac cath via the radial access who are planned for additional radial access cardiac cath Receives: Other: Cath |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess patency of radial artery after repetitive radial artery access
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startJan 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury of Radial ArteryStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- 0 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Amit Segev, MD, Principal investigator, Sheba MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017054
- Sponsor's protocol ID
- SHEBA-13-0827-IB-CTIL
- Status last verified
- May 2016
- First submitted
- 10 Dec 2013
- Last updated
- 18 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Outcomes of Repetitive Radial Approach
- ClinicalTrials.gov ID
- NCT02017054
- Acronym / sponsor ID
- SHEBA-13-0827-IB-CTIL
- Conditions
- Injury of Radial Artery
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 20 Dec 2013 (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 assess the feasibility of performing repetitive coronary angiograms via the radial approach
Detailed description
Assessing succes of radial access in patients with prior TRA procedures
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cath patients | – | Other: CathPatients with previous cardiac cath via the radial access who are planned for additional radial access cardiac cath |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with previous history of trans radial cardiac cath who are planned for additional trans radial cardiac cath
Key inclusion criteria (1 listed)
- Patients with previous successful radial artery approach scheduled for elective transradial coronary angiography
Key exclusion criteria (1 listed)
- Lack of indication to perform radial approach Abnormal Barbeau test result (type C and D) Presence of radial artery occlusion Previous important trauma of the upper limbs Presence of fistula for renal dialysis Lymphoedema Acute myocardial infarction Refusal to sign the informed consent form
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 |
|---|---|---|
| CathAlso: No intervention - registryNo intervention - registry | Other | Cath patients |
Primary outcome
To assess patency of radial artery after repetitive radial artery access
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2017.
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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.
Amit Segev, MD principal investigator
Sheba MC
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 Injury of Radial Artery, run by Sheba 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 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: withdrawn, as of the sponsor's last update on 18 May 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
To assess patency of radial artery after repetitive radial artery access (time frame: 1 month). It is what the study was designed to measure, not a finding.
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 18 May 2017.