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

• ClinicalTrials.gov Identifier: NCT04077762
• Recruitment Status: Recruiting
• First Posted: September 4, 2019
• Last Update Posted: June 28, 2022
• Sponsor: Minneapolis Heart Institute Foundation
• Information provided by (Responsible Party): Minneapolis Heart Institute Foundation

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Patient Satisfaction; Vascular Access Complication	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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 3266 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Radial vs. State-Of-The-Art Femoral Access for Bleeding and Access SIte Complication Reduction in Cardiac Catheterization (REBIRTH)
• Actual Study Start Date: November 15, 2019
• Estimated Primary Completion Date: August 19, 2023
• Estimated Study Completion Date: August 19, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Incidence of the composite of vascular access complications and bleeding (BARC 2, 3, or 5) [ Time Frame: Evaluations will occur up to 30 days ]

Secondary Outcome Measures :

1. Total number of BARC type 2, 3, or 5 bleeding events [ Time Frame: Evaluations will occur up to 30 days ]
2. Number of Vascular access complications defined as the composite of arteriovenous fistula, arterial pseudoaneurysm, or arterial occlusion requiring intervention; [ Time Frame: Evaluations will occur up to 30 days ]
3. Number of participants with Radial artery occlusion [ Time Frame: Evaluations will occur up to 30 days ]
4. Number of participants with Access site crossover [ Time Frame: 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
5. Number of other vascular access related complications [ Time Frame: Evaluations will occur up to 30 days ]
6. Total procedure time [ Time Frame: Measured during procedure ]
   The time from administration of local anesthesia to the time of removal of all interventional equipment
7. Time to ambulation [ Time Frame: Measured up to 24 hours after procedure completion ]
8. Number of all cause death and cardiac death [ Time Frame: Evaluations will occur up to 30 days ]
9. Number of participants with Myocardial Infarction [ Time Frame: Evaluations will occur up to 30 days ]
   The 4th Universal Definition of myocardial infarction
10. Number of participants with Stroke [ Time Frame: Evaluations will occur up to 30 days ]
11. Number of participants with unplanned coronary revascularization [ Time Frame: Evaluations will occur up to 30 days ]
12. Measure of Radiation Dose [ Time Frame: Measured during procedure ]
    Both air kerma and dose air product
13. Fluoroscopy Time [ Time Frame: Measured during procedure ]
14. Contrast volume [ Time Frame: Measured during procedure ]
15. Number of participants with Procedural Success [ Time Frame: Evaluations will occur up to 30 days ]
    Using the National Cardiovascular Disease Registry (NCDR) definition
16. Duration of hospital stay and frequency of same day discharge [ Time Frame: Evaluations will occur up to 30 days ]
17. Patient Preference Survey: Radial Vs Femoral Access [ Time Frame: Evaluations will occur up to 30 days ]
    Participants will be asked which access site they would have preferred to have their procedure

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Bavana Rangan, BDS, MPH, CCRP; 612-863-3852; bavana.rangan@allina.com

Locations

United States, Minnesota

Minneapolis Heart Institute Foundation; Recruiting

Minneapolis, Minnesota, United States, 55407

Contact: Bavana Rangan, BDS, MPH, CCRP 612-863-3852 bavana.rangan@allina.com

Sponsors and Collaborators

Minneapolis Heart Institute Foundation

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Minneapolis Heart Institute Foundation
• ClinicalTrials.gov Identifier: NCT04077762
• Other Study ID Numbers: REBIRTH
• First Posted: September 4, 2019
• Last Update Posted: June 28, 2022
• Last Verified: June 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hemorrhage; Pathologic Processes