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RADIAL Versus Femoral Access for Coronary Artery Bypass Graft Angiography and Intervention (RADIAL-CABG) Trial

NCT ID: NCT01446263

Last Updated: 2013-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-04-30

Brief Summary

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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

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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:

1. similar contrast utilization (primary endpoint)
2. similar procedure time (secondary endpoint)
3. similar fluoroscopy time (secondary endpoint)
4. similar radiation exposure of the patient - measured as DAP \[dose area product\] and AK \[air kerma\] (secondary endpoint)
5. similar radiation exposure of the operators using portable radiation dose measuring devices (secondary endpoint)
6. similar number and types of catheters and guidewires used (secondary endpoint)
7. reduction in vascular access complications (secondary endpoint)
8. reduction in overall complications (vascular access complications,injury, bleeding, death, emergency coronary bypass surgery, stroke, acute myocardial infarction) (secondary endpoint)
9. higher patient satisfaction as measured by standardized survey 24-hours after the procedure (secondary endpoint)

Conditions

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Vascular Access Complication

Keywords

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Radial access Femoral access Coronary angiography Coronary artery bypass graft

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Radial access

Group Type ACTIVE_COMPARATOR

Radial access versus femoral access for coronary angiography and intervention

Intervention Type PROCEDURE

Radial access or femoral access for coronary angiography and intervention in patients with prior coronary artery bypass grafts

Femoral access

Group Type ACTIVE_COMPARATOR

Radial access versus femoral access for coronary angiography and intervention

Intervention Type PROCEDURE

Radial access or femoral access for coronary angiography and intervention in patients with prior coronary artery bypass grafts

Interventions

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Radial access versus femoral access for coronary angiography and intervention

Radial access or femoral access for coronary angiography and intervention in patients with prior coronary artery bypass grafts

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Known pathologic Allen's test
* Known difficulty that limits vascular access at the femoral or radial arteries
* Age \> 90
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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North Texas Veterans Healthcare System

FED

Sponsor Role lead

Responsible Party

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Emmanouil Brilakis

Director, Cardiac Catheterization Laboratories

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emmanouil s Brilakis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

North Texas Veterans Healthcare System

Locations

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Dallas VA Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 24139930 (View on PubMed)

Other Identifiers

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#11-063

Identifier Type: -

Identifier Source: org_study_id