NCT01446263

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

October 29, 2013

Status Verified

October 1, 2013

Enrollment Period

1.5 years

First QC Date

September 29, 2011

Last Update Submit

October 27, 2013

Conditions

Vascular Access Complication

Keywords

Radial accessFemoral accessCoronary angiographyCoronary artery bypass graft

Outcome Measures

Primary Outcomes (1)

  • Amount of contrast used

    24 hours

Secondary Outcomes (9)

  • Total procedure time

    24 hours

  • Fluoroscopy time

    24 hours

  • Radiation exposure of the patients measured as DAP [dose area product] and AK [air kerma]

    24 hours

  • Radiation exposure of the operators as measured as AK using portable radiation dose measuring devices

    24 hours

  • Performance of ascending aortic angiography to identify patent bypass grafts

    24 hours

  • +4 more secondary outcomes

Study Arms (2)

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

Interventions

Radial access versus femoral access for coronary angiography and interventionPROCEDURE

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

Femoral accessRadial access

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

Related Publications (1)

  • 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.

    PMID: 24139930RESULT

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Emmanouil s Brilakis, MD, PhD

    North Texas Veterans Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Cardiac Catheterization Laboratories

Study Record Dates

First Submitted

September 29, 2011

First Posted

October 5, 2011

Study Start

October 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

October 29, 2013

Record last verified: 2013-10

Locations

US(1)