Retrospective ReviewFACRNCT02711514
Femoral Artery Crossover Rates in 1000 Consecutive Radial Cath Labs Procedures.
An observational study of Retrospective Review, run by Miami Cardiac and Vascular Institute at 1 site in United States.
Trial summary
Comparison of Crossover rates of Radial Cardiac Catheterizations and/or PCIs into femoral vs published literature Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Retrospective Review
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Jul 2020
- 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1000 Consecutive Patients who underwent Radial (or Ulnar) Artery Procedures in the Cardiac Cath Lab for Diagnostic Cardiac Catheterizations and/or Percutaneous Coronary Interventions.
Who may be able to join
- Patients coming to the emergency room requiring Diagnostic Cardiac Catheterizations and/or Percutaneous Coronary Interventions
Who cannot join
- Cardiac Tamponade
- Cardiogenic Shock
Trial locations and contacts
1 site in 1 country.
United States1 site
Miami Cardiac and Vascular Institute
Miami, Florida, 33176
About this study
Official title: Femoral Artery Crossover Rates of 1000 Consecutive Radial (or Ulnar) Artery Procedures in the Cardiac Cath Lab for Diagnostic Cardiac Catheterizations and/or Percutaneous Coronary Interventions
Comparison of Crossover rates of Radial Cardiac Catheterizations and/or PCIs into femoral vs published literature
Read the detailed description
A retrospective review of 1000 consecutive Radial or Ulnar Cardiac Catheterizations and/or Percutaneous Coronary Interventions performed in our Institute by one single operator could provide us with the cross over rates to femoral interventions. In this manner these rates could be compared to the published rates of other institutions benchmarking our techniques with the outcomes for such interventions.
- Conditions
- Retrospective Review
What is being measured
The primary outcome is the main question the study is designed to answer.
Crossover rate from Radial to Femoral access
How often do you start a Cath on the Radial Artery and for any reason, have to switch to Femoral Artery.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startDec 2014
- Primary completionJul 2020
- Study completionJul 2020
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retrospective ReviewStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miami Cardiac and Vascular Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raul Herrera, MD, Miami Cardiac and Vascular Institute
- Investigators
- Ramon Quesada, MD, Principal investigator, Director Structural Heart BHSF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711514
- Sponsor's protocol ID
- JR1000R
- Acronym
- FACR
- Status last verified
- Feb 2021
- First submitted
- 14 Mar 2016
- Last updated
- 21 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral Artery Crossover Rates of 1000 Consecutive Radial (or Ulnar) Artery Procedures in the Cardiac Cath Lab for Diagnostic Cardiac Catheterizations and/or Percutaneous Coronary Interventions
- ClinicalTrials.gov ID
- NCT02711514
- Acronym / sponsor ID
- FACR / JR1000R
- Conditions
- Retrospective Review
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Miami Cardiac and Vascular InstituteUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Jul 2020 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 17 Mar 2016 (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.
Comparison of Crossover rates of Radial Cardiac Catheterizations and/or PCIs into femoral vs published literature
Detailed description
A retrospective review of 1000 consecutive Radial or Ulnar Cardiac Catheterizations and/or Percutaneous Coronary Interventions performed in our Institute by one single operator could provide us with the cross over rates to femoral interventions. In this manner these rates could be compared to the published rates of other institutions benchmarking our techniques with the outcomes for such interventions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1000 Consecutive Patients who underwent Radial (or Ulnar) Artery Procedures in the Cardiac Cath Lab for Diagnostic Cardiac Catheterizations and/or Percutaneous Coronary Interventions.
Key inclusion criteria (1 listed)
- Patients coming to the emergency room requiring Diagnostic Cardiac Catheterizations and/or Percutaneous Coronary Interventions
Key exclusion criteria (2 listed)
- Cardiac Tamponade
- Cardiogenic Shock
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
Crossover rate from Radial to Femoral access
Time frame: 1 year
How often do you start a Cath on the Radial Artery and for any reason, have to switch to Femoral Artery.
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
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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.
Ramon Quesada, MD principal investigator
Director Structural Heart BHSF
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 Retrospective Review, run by Miami Cardiac and Vascular Institute at 1 site in United States.
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 2 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: stopped early, as of the sponsor's last update on 21 Feb 2021. 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 United States. 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 stopped early (reason given: COVID-19). 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.
What does the primary outcome measure?
Crossover rate from Radial to Femoral access (time frame: 1 year). 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 21 Feb 2021.