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NCT Number: NCT04077762

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.

Recruiting

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Key information

Conditions

Patient Satisfaction Behavior Health Behavior Treatment Adherence and Compliance Vascular Access Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco VA Medical Center, San Francisco, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radial Access

Procedure

Radial Access

State-of-the-art femoral access with 18 gauge needle

Procedure

State-of-the-art femoral access with 18 gauge needle

State-of-the-art femoral access with 21 gauge needle

Procedure

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 outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Bavana Rangan, BDS, MPH, CCRP

CONTACT

[email protected]

612-863-3852

Olga Mastrodemos

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Minneapolis Heart Institute Foundation

Other

Registry information

Acronym: REBIRTH

Important dates

Study start
2019
Primary completion
2027
Study completion
2028
First posted
Sep 4, 2019
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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