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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radial access | Active Comparator | 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. |
|
| State-of-the-art femoral access | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radial Access | Procedure | Radial Access |
| |
| State-of-the-art femoral access with 18 gauge needle |
| 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 |
| 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; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bavana Rangan, BDS, MPH, CCRP | Contact | 612-863-3852 | bavana.rangan@allina.com | |
| Olga Mastrodemos | Contact | olga.mastrodemos@allina.com |
| Name | Affiliation | Role |
|---|---|---|
| Emmanouil Brilakis, MD, PhD | Minneapolis Heart Institute Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco VA Medical Center | Recruiting | San Francisco | California | 94121 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34637140 | Derived | Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2. |
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| Procedure |
State-of-the-art femoral access with 18 gauge needle |
|
| State-of-the-art femoral access with 21 gauge needle | Procedure | 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. |
|
| 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 |
| Mayo Clinic Florida | Recruiting | Jacksonville | Florida | 32224 | United States |
|
| Joseph Maxwell Cleland Atlanta VA Medical Center | Recruiting | Decatur | Georgia | 30033 | United States |
|
| Henry Ford Hospital | Not yet recruiting | Detroit | Michigan | 48202 | United States |
|
| Minneapolis Heart Institute Foundation | Recruiting | Minneapolis | Minnesota | 55407 | United States |
|
| Oklahoma Heart Hospital | Recruiting | Oklahoma City | Oklahoma | 73120 | United States |
|
| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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