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NCT Number: NCT01446263

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.

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Key information

Conditions

Vascular Access Complication

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dallas VA Medical Center

Dallas, Texas, 75216, United States

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radial access versus femoral access for coronary angiography and intervention

Procedure

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

Primary outcomes

  1. Amount of contrast used

    Time frame: 24 hours

Secondary outcomes

  1. Total procedure time

    Time frame: 24 hours

  2. Fluoroscopy time

    Time frame: 24 hours

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

    Time frame: 24 hours

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

    Time frame: 24 hours

  5. Performance of ascending aortic angiography to identify patent bypass grafts

    Time frame: 24 hours

  6. Number of catheters and wires used

    Time frame: 24 hours

  7. Vascular access complications (hematoma, aneurysm,pseudo-aneurysm, arterio-venous fistula formation, dissection, limb ischemia, bleeding)

    Time frame: 24 hours

  8. Overall Complications (vascular access complications, injury, bleeding, death, emergency coronary bypass surgery, stroke, acute myocardial infarction)

    Time frame: 24 hours

  9. Patient satisfaction, as measured by questionnaire administered 24 hours after the procedure

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

North Texas Veterans Healthcare System

Fed

Registry information

Official study title

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

Acronym: RADIAL-CABG

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 5, 2011
Registry last updated
Oct 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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