Coronary AngiographyTALENTNCT00821106
Left Versus Right Transradial Approach for Percutaneous Coronary Procedures
A study testing Right radial and left radial in people with Coronary Angiography and Angioplasty, Transluminal, Percutaneous Coronary, run by Policlinico Casilino ASL RMB at 2 sites in Italy.
Trial summary
Transradial approach of cardiac catheterization is a common alternative to transfemoral access for diagnostic coronary angiography and percutaneous coronary interventions (PCI). The transradial approach reduces access site bleeding complications and the procedural discomfort of the patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Angiography, Angioplasty, Transluminal, Percutaneous Coronary
- What is being tested?
- Right radial and left radial
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,540 participants
- Where
- 2 sitesItaly
- Study dates
- Jan 2009to Dec 2009
- Phase
- Interventional
- 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
Who may be able to join
- All patients who undergo to diagnostic or interventional procedures
Who cannot join
- Previous coronary artery by-pass
- Acute myocardial infarction with ST segment elevation myocardial infarction
- Cardiogenic shock
- Ischemic Allen Test
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Policlinico Casilino-ASL RMB
Rome
Università Cattolica del Sacro Cuore
Rome
About this study
Official title: Transradial Approach [LEft vs Right] aNd Procedural Times During Percutaneous Coronary Procedures: TALENT Study
Transradial approach of cardiac catheterization is a common alternative to transfemoral access for diagnostic coronary angiography and percutaneous coronary interventions (PCI). The transradial approach reduces access site bleeding complications and the procedural discomfort of the patients. Transradial procedures may be performed by cannulation of the right or left radial artery and at present, the choice of the right or left radial artery depends largely on the operator' s preference.
The aim of this study is to evaluate safety and efficacy of transradial approach comparing the right radial versus the left radial approach in coronary diagnostic and interventional procedures.
Read more
The investigators will enroll consecutively for 12 months all patients who undergo to diagnostic or interventional procedures through trans radial approach in two Italian centers (Casilino Policlinic, Catholic University-Rome).
Primary end point of the study is the fluoroscopy time and the radiation dose adsorbed by the patients. Secondary end-points are: contrast amount, time to obtain the first angiography, procedural shift rate, number of catheters employed, major complications.
The investigators pre-specified a sub-study in patients older than 75 years old with the same end-points.
- Being tested
- Right radial, left radial
- Keywords
- Coronary angiography, percutaneous coronary intervention, Transradial approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right radialProcedure or surgery
diagnostic or interventional procedures performed through right transradial approach
left radialProcedure or surgery
diagnostic or interventional procedures performed through left transradial approach
| Study group | Role | What they receive |
|---|---|---|
| Right transradial approach | Experimental | Coronary diagnostic or interventional procedures performed through right radial approach Receives: Procedure: Right radial |
| Left transradial approach | Experimental | Diagnostic or interventional procedures performed through left radial approach Receives: Procedure: left radial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary end point of the study is the fluoroscopy time of the procedure and the radiation dose adsorbed by the patients
Measured: 7 days
Secondary outcomes (1)
Contrast amount, time to obtain the first angiography, procedural shift rate, number of catheters employed, major complications.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary AngiographyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Policlinico Casilino ASL RMB
- Sponsor type
- University, hospital or other
- Investigators
- Alessandro Sciahbasi, MD, Principal investigator, Policlinico Casilino ASL RMB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821106
- Sponsor's protocol ID
- TALENT
- Acronym
- TALENT
- Status last verified
- Jan 2010
- First submitted
- 9 Jan 2009
- Last updated
- 19 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transradial Approach [LEft vs Right] aNd Procedural Times During Percutaneous Coronary Procedures: TALENT Study
- ClinicalTrials.gov ID
- NCT00821106
- Acronym / sponsor ID
- TALENT / TALENT
- Keywords
- Coronary angiography, percutaneous coronary intervention, Transradial approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,540 participants (actual)
- Lead sponsor
- Policlinico Casilino ASL RMBUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 13 Jan 2009 (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 approach of cardiac catheterization is a common alternative to transfemoral access for diagnostic coronary angiography and percutaneous coronary interventions (PCI). The transradial approach reduces access site bleeding complications and the procedural discomfort of the patients. Transradial procedures may be performed by cannulation of the right or left radial artery and at present, the choice of the right or left radial artery depends largely on the operator' s preference.
The aim of this study is to evaluate safety and efficacy of transradial approach comparing the right radial versus the left radial approach in coronary diagnostic and interventional procedures.
The investigators will enroll consecutively for 12 months all patients who undergo to diagnostic or interventional procedures through trans radial approach in two Italian centers (Casilino Policlinic, Catholic University-Rome).
Primary end point of the study is the fluoroscopy time and the radiation dose adsorbed by the patients. Secondary end-points are: contrast amount, time to obtain the first angiography, procedural shift rate, number of catheters employed, major complications.
The investigators pre-specified a sub-study in patients older than 75 years old with the same end-points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right transradial approach | Experimental | Procedure: Right radialCoronary diagnostic or interventional procedures performed through right radial approach |
| Left transradial approach | Experimental | Procedure: left radialDiagnostic or interventional procedures performed through left radial approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who undergo to diagnostic or interventional procedures
Key exclusion criteria (4 listed)
- Previous coronary artery by-pass
- Acute myocardial infarction with ST segment elevation myocardial infarction
- Cardiogenic shock
- Ischemic Allen Test
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 |
|---|---|---|
| Right radialdiagnostic or interventional procedures performed through right transradial approach | Procedure or surgery | Right transradial approach |
| left radialdiagnostic or interventional procedures performed through left transradial approach | Procedure or surgery | Left transradial approach |
Primary outcome
Primary end point of the study is the fluoroscopy time of the procedure and the radiation dose adsorbed by the patients
Time frame: 7 days
1 secondary outcome
Contrast amount, time to obtain the first angiography, procedural shift rate, number of catheters employed, major complications.
Time frame: 7 days
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 19 Mar 2010.
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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.
Alessandro Sciahbasi, MD principal investigator
Policlinico Casilino ASL RMB
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Right radial and left radial in people with Coronary Angiography and Angioplasty, Transluminal, Percutaneous Coronary, run by Policlinico Casilino ASL RMB at 2 sites in Italy.
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 4 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 19 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Primary end point of the study is the fluoroscopy time of the procedure and the radiation dose adsorbed by the patients (time frame: 7 days). 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 19 Mar 2010.