Vascular Access ComplicationPhase 3RADIAL-CABGNCT01446263
RADIAL Versus Femoral Access for Coronary Artery Bypass Graft Angiography and Intervention (RADIAL-CABG) Trial
A Phase 3 study testing Radial access versus femoral access for coronary angiography and intervention in people with Vascular Access Complication, run by North Texas Veterans Healthcare System at 1 site in United States.
Trial summary
Increased use of radial access for cardiac catheterization is being advocated because studies have showed lower arterial access related complication rates and higher patient satisfaction as compared to femoral access. However, little is known on patients with prior coronary artery bypass graft (CABG). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Vascular Access Complication
- What is being tested?
- Radial access versus femoral access for coronary angiography and intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Apr 2013
- Phase
- Phase 3
- 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
Who may be able to join
- Age >18-years
- Prior coronary artery bypass graft surgery
- Referred for clinically-indicated coronary and graft angiography and/or intervention
- Able to provide informed consent
Who cannot join
- Known pathologic Allen's test
- Known difficulty that limits vascular access at the femoral or radial arteries
- Age > 90
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Comparison of RADIAL Versus Femoral Access for Coronary Artery Bypass Graft Angiography and Intervention (RADIAL-CABG) Trial
Increased use of radial access for cardiac catheterization is being advocated because studies have showed lower arterial access related complication rates and higher patient satisfaction as compared to femoral access. However, little is known on patients with prior coronary artery bypass graft (CABG). The RADIAL CABG Trial is a randomized-controlled trial proposed to test the hypothesis that bypass graft angiography and intervention via radial access provides lower vascular complication rates, similar contrast and equipment utilization and higher patient satisfaction when compared with transfemoral approach.
Read the detailed description
This is a phase III, single-center, prospective, randomized trial that will compare resource utilization, clinical outcomes and patient satisfaction between radial and femoral access for patients with prior coronary artery bypass graft (CABG)surgery undergoing coronary and graft angiography and intervention. During clinically-indicated coronary angiography of patients with prior CABG, the amount resources used, radiation exposure to patients and operators, occurence of complications and patients satisfaction will be compared between the two treatment arms to determine whether compared to femoral approach radial access will result in:
- similar contrast utilization (primary endpoint)
- similar procedure time (secondary endpoint)
- similar fluoroscopy time (secondary endpoint)
- similar radiation exposure of the patient - measured as DAP [dose area product] and AK [air kerma] (secondary endpoint)
- similar radiation exposure of the operators using portable radiation dose measuring devices (secondary endpoint)
- similar number and types of catheters and guidewires used (secondary endpoint)
- reduction in vascular access complications (secondary endpoint)
- reduction in overall complications (vascular access complications,injury, bleeding, death, emergency coronary bypass surgery, stroke, acute myocardial infarction) (secondary endpoint)
- higher patient satisfaction as measured by standardized survey 24-hours after the procedure (secondary endpoint)
- Conditions
- Vascular Access Complication
- Being tested
- Radial access versus femoral access for coronary angiography and intervention
- Keywords
- Radial access, Femoral access, Coronary angiography, Coronary artery bypass graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial access versus femoral access for coronary angiography and interventionProcedure or surgery
Radial access or femoral access for coronary angiography and intervention in patients with prior coronary artery bypass grafts
| Study group | Role | What they receive |
|---|---|---|
| Radial access | Active comparator | Not described Receives: Procedure: Radial access versus femoral access for coronary angiography and intervention |
| Femoral access | Active comparator | Not described Receives: Procedure: Radial access versus femoral access for coronary angiography and intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of contrast used
Measured: 24 hours
Secondary outcomes (9)
Total procedure time
Measured: 24 hours
Fluoroscopy time
Measured: 24 hours
Radiation exposure of the patients measured as DAP [dose area product] and AK [air kerma]
Measured: 24 hours
Radiation exposure of the operators as measured as AK using portable radiation dose measuring devices
Measured: 24 hours
Performance of ascending aortic angiography to identify patent bypass grafts
Measured: 24 hours
Number of catheters and wires used
Measured: 24 hours
Vascular access complications (hematoma, aneurysm,pseudo-aneurysm, arterio-venous fistula formation, dissection, limb ischemia, bleeding)
Measured: 24 hours
Overall Complications (vascular access complications, injury, bleeding, death, emergency coronary bypass surgery, stroke, acute myocardial infarction)
Measured: 24 hours
Patient satisfaction, as measured by questionnaire administered 24 hours after the procedure
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2013
- Study completionApr 2013
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 Vascular Access ComplicationStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Texas Veterans Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Emmanouil Brilakis, North Texas Veterans Healthcare System
- Investigators
- Emmanouil s Brilakis, MD, PhD, Principal investigator, North Texas Veterans Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446263
- Sponsor's protocol ID
- #11-063
- Acronym
- RADIAL-CABG
- Status last verified
- Oct 2013
- First submitted
- 29 Sep 2011
- Last updated
- 29 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Michael TT, Alomar M, Papayannis A, Mogabgab O, Patel VG, Rangan BV, Luna M, Hastings JL, Grodin J, Abdullah S, Banerjee S, Brilakis ES. A randomized comparison of the transradial and transfemoral approaches for coronary artery bypass graft angiography and intervention: the RADIAL-CABG Trial (RADIAL Versus Femoral Access for Coronary Artery Bypass Graft Angiography and Intervention). JACC Cardiovasc Interv. 2013 Nov;6(11):1138-44. doi: 10.1016/j.jcin.2013.08.004. Epub 2013 Oct 16.
PubMed 24139930
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of RADIAL Versus Femoral Access for Coronary Artery Bypass Graft Angiography and Intervention (RADIAL-CABG) Trial
- ClinicalTrials.gov ID
- NCT01446263
- Acronym / sponsor ID
- RADIAL-CABG / #11-063
- Conditions
- Vascular Access Complication
- Keywords
- Radial access, Femoral access, Coronary angiography, Coronary artery bypass graft
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- North Texas Veterans Healthcare SystemUS federal agency
- Study start
- Oct 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 5 Oct 2011 (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.
Increased use of radial access for cardiac catheterization is being advocated because studies have showed lower arterial access related complication rates and higher patient satisfaction as compared to femoral access. However, little is known on patients with prior coronary artery bypass graft (CABG). The RADIAL CABG Trial is a randomized-controlled trial proposed to test the hypothesis that bypass graft angiography and intervention via radial access provides lower vascular complication rates, similar contrast and equipment utilization and higher patient satisfaction when compared with transfemoral approach.
Detailed description
This is a phase III, single-center, prospective, randomized trial that will compare resource utilization, clinical outcomes and patient satisfaction between radial and femoral access for patients with prior coronary artery bypass graft (CABG)surgery undergoing coronary and graft angiography and intervention. During clinically-indicated coronary angiography of patients with prior CABG, the amount resources used, radiation exposure to patients and operators, occurence of complications and patients satisfaction will be compared between the two treatment arms to determine whether compared to femoral approach radial access will result in:
- similar contrast utilization (primary endpoint)
- similar procedure time (secondary endpoint)
- similar fluoroscopy time (secondary endpoint)
- similar radiation exposure of the patient - measured as DAP [dose area product] and AK [air kerma] (secondary endpoint)
- similar radiation exposure of the operators using portable radiation dose measuring devices (secondary endpoint)
- similar number and types of catheters and guidewires used (secondary endpoint)
- reduction in vascular access complications (secondary endpoint)
- reduction in overall complications (vascular access complications,injury, bleeding, death, emergency coronary bypass surgery, stroke, acute myocardial infarction) (secondary endpoint)
- higher patient satisfaction as measured by standardized survey 24-hours after the procedure (secondary endpoint)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radial access | Active comparator | Procedure: Radial access versus femoral access for coronary angiography and intervention |
| Femoral access | Active comparator | Procedure: Radial access versus femoral access for coronary angiography and intervention |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18-years
- Prior coronary artery bypass graft surgery
- Referred for clinically-indicated coronary and graft angiography and/or intervention
- Able to provide informed consent
Key exclusion criteria (3 listed)
- Known pathologic Allen's test
- Known difficulty that limits vascular access at the femoral or radial arteries
- Age > 90
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 |
|---|---|---|
| Radial access versus femoral access for coronary angiography and interventionRadial access or femoral access for coronary angiography and intervention in patients with prior coronary artery bypass grafts | Procedure or surgery | Femoral access, Radial access |
Primary outcome
Amount of contrast used
Time frame: 24 hours
9 secondary outcomes
Total procedure time
Time frame: 24 hours
Fluoroscopy time
Time frame: 24 hours
Radiation exposure of the patients measured as DAP [dose area product] and AK [air kerma]
Time frame: 24 hours
Radiation exposure of the operators as measured as AK using portable radiation dose measuring devices
Time frame: 24 hours
Performance of ascending aortic angiography to identify patent bypass grafts
Time frame: 24 hours
Number of catheters and wires used
Time frame: 24 hours
Vascular access complications (hematoma, aneurysm,pseudo-aneurysm, arterio-venous fistula formation, dissection, limb ischemia, bleeding)
Time frame: 24 hours
Overall Complications (vascular access complications, injury, bleeding, death, emergency coronary bypass surgery, stroke, acute myocardial infarction)
Time frame: 24 hours
Patient satisfaction, as measured by questionnaire administered 24 hours after the procedure
Time frame: 24 hours
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 29 Oct 2013.
- Results publication: PubMed 24139930Michael TT, Alomar M, Papayannis A, Mogabgab O, Patel VG, Rangan BV, Luna M, Hastings JL, Grodin J, Abdullah S, Banerjee S, Brilakis ES. A randomized comparison of the transradial and transfemoral approaches for coronary artery bypass graft angiography and intervention: the RADIAL-CABG Trial (RADIAL Versus Femoral Access for Coronary Artery Bypass Graft Angiography and Intervention). JACC Cardiovasc Interv. 2013 Nov;6(11):1138-44. doi: 10.1016/j.jcin.2013.08.004. Epub 2013 Oct 16.
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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.
Emmanouil s Brilakis, MD, PhD principal investigator
North Texas Veterans Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radial access versus femoral access for coronary angiography and intervention in people with Vascular Access Complication, run by North Texas Veterans Healthcare System 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 4 inclusion and 3 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 29 Oct 2013. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Amount of contrast used (time frame: 24 hours). 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 NCT01446263, 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 29 Oct 2013.