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

Vascular Access Complication Clinical Trial

— RADIAL-CABG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01446263
• Other study ID #: #11-063
• Status: Completed
• Phase: Phase 3
• First received: September 29, 2011
• Last updated: October 27, 2013
• Start date: October 2011
• Est. completion date: April 2013

Study information

• Verified date: October 2013
• Source: North Texas Veterans Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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). 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.

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:

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Vascular Access Complication

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
United States	Dallas VA Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
North Texas Veterans Healthcare System

Country where clinical trial is conducted

United States, 

References & 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 an — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of contrast used		24 hours	Yes
Secondary	Total procedure time		24 hours	Yes
Secondary	Fluoroscopy time		24 hours	Yes
Secondary	Radiation exposure of the patients measured as DAP [dose area product] and AK [air kerma]		24 hours	Yes
Secondary	Radiation exposure of the operators as measured as AK using portable radiation dose measuring devices		24 hours	Yes
Secondary	Performance of ascending aortic angiography to identify patent bypass grafts		24 hours	No
Secondary	Number of catheters and wires used		24 hours	No
Secondary	Vascular access complications (hematoma, aneurysm,pseudo-aneurysm, arterio-venous fistula formation, dissection, limb ischemia, bleeding)		24 hours	Yes
Secondary	Overall Complications (vascular access complications, injury, bleeding, death, emergency coronary bypass surgery, stroke, acute myocardial infarction)		24 hours	Yes
Secondary	Patient satisfaction, as measured by questionnaire administered 24 hours after the procedure		24 hours	No