This is a phase IV, prospective, open label, randomized-controlled study that will compare radial access with state-of-the-art femoral access in patients without ST-segment elevation acute myocardial infarction undergoing cardiac catheterization. Subjects will be randomized 1:1 into 2 treatment groups: radial access and state-of-the-art femoral access. Randomization will be performed in blocks of 50 per site. Similarly, a second sub-randomization will be performed in the femoral access group into use of 18 vs 21 gauge needles, also in a 1:1 fashion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3,266
Radial Access
State-of-the-art femoral access with 18 gauge needle
State-of-the-art femoral access with 21 gauge needle. For patients randomized to micropuncture (21G) the micropuncture wire must be advanced under fluoroscopy to avoid inadvertent wiring of side-branches.
San Francisco VA Medical Center
San Francisco, California, United States
RECRUITINGMayo Clinic Florida
Jacksonville, Florida, United States
RECRUITINGJoseph Maxwell Cleland Atlanta VA Medical Center
Decatur, Georgia, United States
RECRUITINGHenry Ford Hospital
Detroit, Michigan, United States
NOT_YET_RECRUITINGMinneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
RECRUITINGOklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
RECRUITINGIncidence of the composite of vascular access complications and bleeding (BARC 2, 3, or 5)
Time frame: Evaluations will occur up to 30 days
Total number of BARC type 2, 3, or 5 bleeding events
Time frame: Evaluations will occur up to 30 days
Number of Vascular access complications defined as the composite of arteriovenous fistula, arterial pseudoaneurysm, or arterial occlusion requiring intervention;
Time frame: Evaluations will occur up to 30 days
Number of participants with Radial artery occlusion
Time frame: Evaluations will occur up to 30 days
Number of participants with Access site crossover
The inability to complete the procedure from the assigned arterial access site, requiring conversion from radial to femoral access or vice versa for procedure completion
Time frame: Measured during procedure
Number of other vascular access related complications
Time frame: Evaluations will occur up to 30 days
Total procedure time
The time from administration of local anesthesia to the time of removal of all interventional equipment
Time frame: Measured during procedure
Time to ambulation
Time frame: Measured up to 24 hours after procedure completion
Number of all cause death and cardiac death
Time frame: Evaluations will occur up to 30 days
Number of participants with Myocardial Infarction
The 4th Universal Definition of myocardial infarction
Time frame: Evaluations will occur up to 30 days
Number of participants with Stroke
Time frame: Evaluations will occur up to 30 days
Number of participants with unplanned coronary revascularization
Time frame: Evaluations will occur up to 30 days
Measure of Radiation Dose
Both air kerma and dose air product
Time frame: Measured during procedure
Fluoroscopy Time
Time frame: Measured during procedure
Contrast volume
Time frame: Measured during procedure
Number of participants with Procedural Success
Using the National Cardiovascular Disease Registry (NCDR) definition
Time frame: Evaluations will occur up to 30 days
Duration of hospital stay and frequency of same day discharge
Time frame: Evaluations will occur up to 30 days
Patient Preference Survey: Radial Vs Femoral Access
Participants will be asked which access site they would have preferred to have their procedure
Time frame: Evaluations will occur up to 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.