Patient Satisfaction, Vascular Access Complication
Conditions
Brief summary
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.
Interventions
PROCEDURERadial Access
Radial Access
PROCEDUREState-of-the-art femoral access with 18 gauge needle
State-of-the-art femoral access with 18 gauge needle
PROCEDUREState-of-the-art femoral access with 21 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.
Sponsors
Minneapolis Heart Institute Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Duration of hospital stay and frequency of same day discharge | Evaluations will occur up to 30 days | — |
| Patient Preference Survey: Radial Vs Femoral Access | Evaluations will occur up to 30 days | Participants will be asked which access site they would have preferred to have their procedure |
| Contrast volume | 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 | Evaluations will occur up to 30 days | The 4th Universal Definition of myocardial infarction |
| 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 | Measured during procedure | Both air kerma and dose air product |
| Fluoroscopy Time | Measured during procedure | — |
| Total procedure time | Measured during procedure | The time from administration of local anesthesia to the time of removal of all interventional equipment |
| 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 | Measured during procedure | 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 |
| Number of participants with Procedural Success | Evaluations will occur up to 30 days | Using the National Cardiovascular Disease Registry (NCDR) definition |
| Number of other vascular access related complications | Evaluations will occur up to 30 days | — |
Countries
United States
Contacts
CONTACTBavana Rangan, BDS, MPH, CCRP
CONTACTOlga Mastrodemos
PRINCIPAL_INVESTIGATOREmmanouil Brilakis, MD, PhD
Minneapolis Heart Institute Foundation
Outcome results
None listed