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

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

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 Overview

• Status: Recruiting
• Conditions: Patient Satisfaction; Vascular Access Complication
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Anticipated): 3266
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bavana Rangan, BDS, MPH, CCRP; Phone Number: 612-863-3852; Email: bavana.rangan@allina.com

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Recruiting
      • Minneapolis Heart Institute Foundation
      • Contact: Bavana Rangan, BDS, MPH, CCRP; Phone Number: 612-863-3852; Email: bavana.rangan@allina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Radial access; 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; Radial Access
ACTIVE_COMPARATOR: State-of-the-art femoral access; 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; State-of-the-art femoral access with 18 gauge needle; Procedure: State-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.

What is the study measuring?

Primary Outcome Measures

Outcome 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 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

Collaborators and Investigators

• Sponsor: Minneapolis Heart Institute Foundation
• Investigators: Principal Investigator: Emmanouil Brilakis, MD, PhD, Minneapolis Heart Institute Foundation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 15, 2019
• Primary Completion (ANTICIPATED): August 19, 2023
• Study Completion (ANTICIPATED): August 19, 2024

Study Registration Dates

• First Submitted: August 26, 2019
• First Submitted That Met QC Criteria: September 3, 2019
• First Posted (ACTUAL): September 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: REBIRTH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No