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

Primary Purpose

Patient Satisfaction, Vascular Access Complication

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Radial Access
State-of-the-art femoral access with 18 gauge needle
State-of-the-art femoral access with 21 gauge needle
Sponsored by
Minneapolis Heart Institute Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patient Satisfaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Minneapolis Heart Institute FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Radial access

State-of-the-art femoral access

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Incidence of the composite of vascular access complications and bleeding (BARC 2, 3, or 5)

Secondary Outcome Measures

Total number of BARC type 2, 3, or 5 bleeding events
Number of Vascular access complications defined as the composite of arteriovenous fistula, arterial pseudoaneurysm, or arterial occlusion requiring intervention;
Number of participants with Radial artery occlusion
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
Number of other vascular access related complications
Total procedure time
The time from administration of local anesthesia to the time of removal of all interventional equipment
Time to ambulation
Number of all cause death and cardiac death
Number of participants with Myocardial Infarction
The 4th Universal Definition of myocardial infarction
Number of participants with Stroke
Number of participants with unplanned coronary revascularization
Measure of Radiation Dose
Both air kerma and dose air product
Fluoroscopy Time
Contrast volume
Number of participants with Procedural Success
Using the National Cardiovascular Disease Registry (NCDR) definition
Duration of hospital stay and frequency of same day discharge
Patient Preference Survey: Radial Vs Femoral Access
Participants will be asked which access site they would have preferred to have their procedure

Full Information

First Posted
August 26, 2019
Last Updated
June 27, 2022
Sponsor
Minneapolis Heart Institute Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04077762
Brief Title
Radial vs. State-Of-The-Art Femoral Access for Bleeding and Access Site Complication Reduction in Cardiac Catheterization (REBIRTH)
Acronym
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2019 (Actual)
Primary Completion Date
August 19, 2023 (Anticipated)
Study Completion Date
August 19, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Minneapolis Heart Institute Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Satisfaction, Vascular Access Complication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3266 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radial access
Arm Type
Active Comparator
Arm Description
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.
Arm Title
State-of-the-art femoral access
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Radial Access
Intervention Description
Radial Access
Intervention Type
Procedure
Intervention Name(s)
State-of-the-art femoral access with 18 gauge needle
Intervention Description
State-of-the-art femoral access with 18 gauge needle
Intervention Type
Procedure
Intervention Name(s)
State-of-the-art femoral access with 21 gauge needle
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Total number of BARC type 2, 3, or 5 bleeding events
Time Frame
Evaluations will occur up to 30 days
Title
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
Title
Number of participants with Radial artery occlusion
Time Frame
Evaluations will occur up to 30 days
Title
Number of participants with Access site crossover
Description
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
Time Frame
Measured during procedure
Title
Number of other vascular access related complications
Time Frame
Evaluations will occur up to 30 days
Title
Total procedure time
Description
The time from administration of local anesthesia to the time of removal of all interventional equipment
Time Frame
Measured during procedure
Title
Time to ambulation
Time Frame
Measured up to 24 hours after procedure completion
Title
Number of all cause death and cardiac death
Time Frame
Evaluations will occur up to 30 days
Title
Number of participants with Myocardial Infarction
Description
The 4th Universal Definition of myocardial infarction
Time Frame
Evaluations will occur up to 30 days
Title
Number of participants with Stroke
Time Frame
Evaluations will occur up to 30 days
Title
Number of participants with unplanned coronary revascularization
Time Frame
Evaluations will occur up to 30 days
Title
Measure of Radiation Dose
Description
Both air kerma and dose air product
Time Frame
Measured during procedure
Title
Fluoroscopy Time
Time Frame
Measured during procedure
Title
Contrast volume
Time Frame
Measured during procedure
Title
Number of participants with Procedural Success
Description
Using the National Cardiovascular Disease Registry (NCDR) definition
Time Frame
Evaluations will occur up to 30 days
Title
Duration of hospital stay and frequency of same day discharge
Time Frame
Evaluations will occur up to 30 days
Title
Patient Preference Survey: Radial Vs Femoral Access
Description
Participants will be asked which access site they would have preferred to have their procedure
Time Frame
Evaluations will occur up to 30 days

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bavana Rangan, BDS, MPH, CCRP
Phone
612-863-3852
Email
bavana.rangan@allina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanouil Brilakis, MD, PhD
Organizational Affiliation
Minneapolis Heart Institute Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minneapolis Heart Institute Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bavana Rangan, BDS, MPH, CCRP
Phone
612-863-3852
Email
bavana.rangan@allina.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
34637140
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.
Results Reference
derived

Learn more about this trial

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

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