Radial vs. State-Of-The-Art Femoral Access for Bleeding and Access Site Complication Reduction in Cardiac Catheterization (REBIRTH)

Study Overview
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Brief Summary
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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.

Official Title
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Radial vs. State-Of-The-Art Femoral Access for Bleeding and Access SIte Complication Reduction in Cardiac Catheterization (REBIRTH)

Conditions
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Patient Satisfaction, Vascular Access Complication

Intervention / Treatment
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* Procedure: Radial Access
* Procedure: State-of-the-art femoral access with 18 gauge needle
* Procedure: State-of-the-art femoral access with 21 gauge needle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and older Undergoing diagnostic angiography for ischemic symptoms with possible PCI, or undergoing planned urgent or elective PCI Has provided informed consent and agrees to participate Patients must be equally eligible to undergo cardiac catheterization via radial or femoral access Exclusion Criteria: Primary PCI for STEMI Planned right heart catheterization Valvular heart disease requiring valve surgery within 30 days after the index procedure Hemodialysis access (arteriovenous fistula or graft) in the arm to be used for PCI in case of assignment to radial approach (the opposite arm may be used for radial access if a dialysis graft is present in one) Peripheral arterial disease prohibiting vascular access Presence of bilateral internal mammary artery coronary bypass grafts International normalized ratio ≥1.5 while treated with oral vitamin K antagonists (i.e. warfarin) Receipt of oral factor Xa or IIa inhibitors ≤24 h before procedure Planned staged PCI within 30 days after index procedure. Any planned surgeries within 30 days after index procedure Planned dual arterial access (for example for chronic total occlusion PCI) Coexisting conditions that limit life expectancy to less than 30 days Positive pregnancy test

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Radial access<br>Radial access for cardiac catheterization. Radial access will be performed using ultrasound guidance and a micropuncture needle or catheter-over-needle system, as per the local standard of care. | Procedure: Radial Access<br>* Radial Access<br>|
| Active Comparator: State-of-the-art femoral access<br>Femoral access for cardiac catheterization. Femoral access will be obtained using state-of-the-art techniques (ultrasound and fluoroscopic guidance for arterial puncture, immediate femoral angiography after obtaining access and use of a vascular closure device whenever possible). | Procedure: State-of-the-art femoral access with 18 gauge needle<br>* State-of-the-art femoral access with 18 gauge needle<br>Procedure: State-of-the-art femoral access with 21 gauge needle<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of the composite of vascular access complications and bleeding (BARC 2, 3, or 5) |  | Evaluations will occur up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of BARC type 2, 3, or 5 bleeding events |  | 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; |  | Evaluations will occur up to 30 days | 
| Number of participants with Radial artery occlusion |  | 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 | Measured during procedure | 
| Number of other vascular access related complications |  | 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 | Measured during procedure | 
| Time to ambulation |  | Measured up to 24 hours after procedure completion | 
| Number of all cause death and cardiac death |  | Evaluations will occur up to 30 days | 
| Number of participants with Myocardial Infarction | The 4th Universal Definition of myocardial infarction | Evaluations will occur up to 30 days | 
| Number of participants with Stroke |  | Evaluations will occur up to 30 days | 
| Number of participants with unplanned coronary revascularization |  | Evaluations will occur up to 30 days | 
| Measure of Radiation Dose | Both air kerma and dose air product | Measured during procedure | 
| Fluoroscopy Time |  | Measured during procedure | 
| Contrast volume |  | Measured during procedure | 
| Number of participants with Procedural Success | Using the National Cardiovascular Disease Registry (NCDR) definition | Evaluations will occur up to 30 days | 
| Duration of hospital stay and frequency of same day discharge |  | 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 | Evaluations will occur up to 30 days |