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Trial record 1 of 37 for:    reduction in access site complications
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Radial vs. State-Of-The-Art Femoral Access for Bleeding and Access Site Complication Reduction in Cardiac Catheterization (REBIRTH) (REBIRTH)

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ClinicalTrials.gov Identifier: NCT04077762
Recruitment Status : Recruiting
First Posted : September 4, 2019
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
Minneapolis Heart Institute Foundation

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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.




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04077762


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

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

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Responsible Party: Minneapolis Heart Institute Foundation
ClinicalTrials.gov Identifier: NCT04077762    
Other Study ID Numbers: REBIRTH
First Posted: September 4, 2019    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes