Clinical trial NCT04077762: Radial Vs. State-Of-The-Art Femoral Access for Bleeding and Access Site Complication Reduction in Cardiac Catheterization (REBIRTH)
Official title: Radial Vs. State-Of-The-Art Femoral Access for Bleeding and Access SIte Complication Reduction in Cardiac Catheterization (REBIRTH)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patient Satisfaction
Vascular Access Complication
Lead sponsor: Minneapolis Heart Institute Foundation
Sponsor class: OTHER
First posted: 2019-09-04
Enrollment: 3266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of the composite of vascular access complications and bleeding (BARC 2, 3, or 5)
timeFrame: Evaluations will occur up to 30 days
Secondary outcomes:
measure: Total number of BARC type 2, 3, or 5 bleeding events
timeFrame: Evaluations will occur up to 30 days
measure: Number of Vascular access complications defined as the composite of arteriovenous fistula, arterial pseudoaneurysm, or arterial occlusion requiring intervention;
timeFrame: Evaluations will occur up to 30 days
measure: Number of participants with Radial artery occlusion
timeFrame: Evaluations will occur up to 30 days
measure: Number of participants with Access site crossover
timeFrame: Measured during procedure
measure: Number of other vascular access related complications
timeFrame: Evaluations will occur up to 30 days
measure: Total procedure time
timeFrame: Measured during procedure
measure: Time to ambulation
timeFrame: Measured up to 24 hours after procedure completion
measure: Number of all cause death and cardiac death
timeFrame: Evaluations will occur up to 30 days
measure: Number of participants with Myocardial Infarction
timeFrame: Evaluations will occur up to 30 days
measure: Number of participants with Stroke
timeFrame: Evaluations will occur up to 30 days
measure: Number of participants with unplanned coronary revascularization
timeFrame: Evaluations will occur up to 30 days
measure: Measure of Radiation Dose
timeFrame: Measured during procedure
measure: Fluoroscopy Time
timeFrame: Measured during procedure
measure: Contrast volume
timeFrame: Measured during procedure
measure: Number of participants with Procedural Success
timeFrame: Evaluations will occur up to 30 days
measure: Duration of hospital stay and frequency of same day discharge
timeFrame: Evaluations will occur up to 30 days
measure: Patient Preference Survey: Radial Vs Femoral Access
timeFrame: Evaluations will occur up to 30 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Decatur
country: United States
facility: Joseph Maxwell Cleland Atlanta VA Medical Center
state: Georgia
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
Study officials:
affiliation: Minneapolis Heart Institute Foundation
name: Emmanouil Brilakis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.