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

Patient Satisfaction Clinical Trial

— REBIRTH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04077762
• Other study ID #: REBIRTH
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2019
• Est. completion date: August 19, 2024

Study information

• Verified date: June 2022
• Source: Minneapolis Heart Institute Foundation
• Contact: Bavana Rangan, BDS, MPH, CCRP
• Phone: 612-863-3852
• Email: bavana.rangan[@]allina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3266
• Est. completion date: August 19, 2024
• Est. primary completion date: August 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Patient Satisfaction
• Vascular Access Complication

Intervention

Procedure:
• Radial Access
Radial Access
• State-of-the-art femoral access with 18 gauge needle
State-of-the-art femoral access with 18 gauge needle
• 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.

Locations

Country	Name	City	State
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Heart Institute Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of the composite of vascular access complications and bleeding (BARC 2, 3, or 5)		Evaluations will occur up to 30 days
Secondary	Total number of BARC type 2, 3, or 5 bleeding events		Evaluations will occur up to 30 days
Secondary	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
Secondary	Number of participants with Radial artery occlusion		Evaluations will occur up to 30 days
Secondary	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
Secondary	Number of other vascular access related complications		Evaluations will occur up to 30 days
Secondary	Total procedure time	The time from administration of local anesthesia to the time of removal of all interventional equipment	Measured during procedure
Secondary	Time to ambulation		Measured up to 24 hours after procedure completion
Secondary	Number of all cause death and cardiac death		Evaluations will occur up to 30 days
Secondary	Number of participants with Myocardial Infarction	The 4th Universal Definition of myocardial infarction	Evaluations will occur up to 30 days
Secondary	Number of participants with Stroke		Evaluations will occur up to 30 days
Secondary	Number of participants with unplanned coronary revascularization		Evaluations will occur up to 30 days
Secondary	Measure of Radiation Dose	Both air kerma and dose air product	Measured during procedure
Secondary	Fluoroscopy Time		Measured during procedure
Secondary	Contrast volume		Measured during procedure
Secondary	Number of participants with Procedural Success	Using the National Cardiovascular Disease Registry (NCDR) definition	Evaluations will occur up to 30 days
Secondary	Duration of hospital stay and frequency of same day discharge		Evaluations will occur up to 30 days
Secondary	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