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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01446263
Other study ID # #11-063
Secondary ID
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


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
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