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Recruiting NCT04077762

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

No phase Interventional Patient Satisfaction Vascular Access Complication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radial Access, State-of-the-art femoral access with 18 gauge needle, State-of-the-art femoral access with 21 gauge needle.
Who it may be relevant to
Registry conditions: Patient Satisfaction, Vascular Access Complication. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure Radial Access
    Radial Access
  • 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

  • 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 (12)
  • Total number of BARC type 2, 3, or 5 bleeding events [Time frame: Evaluations will occur up to 30 days]
  • 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]
  • Number of participants with Radial artery occlusion [Time frame: Evaluations will occur up to 30 days]
  • Number of participants with Access site crossover [Time frame: Measured during procedure]
  • Number of other vascular access related complications [Time frame: Evaluations will occur up to 30 days]
  • Total procedure time [Time frame: Measured during procedure]
  • Time to ambulation [Time frame: Measured up to 24 hours after procedure completion]
  • Number of all cause death and cardiac death [Time frame: Evaluations will occur up to 30 days]
  • Number of participants with Myocardial Infarction [Time frame: Evaluations will occur up to 30 days]
  • Number of participants with Stroke [Time frame: Evaluations will occur up to 30 days]
  • Number of participants with unplanned coronary revascularization [Time frame: Evaluations will occur up to 30 days]
  • Measure of Radiation Dose [Time frame: Measured during procedure]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 6 centers
  • San Francisco VA Medical Center — San Francisco
  • Mayo Clinic Florida — Jacksonville
  • Joseph Maxwell Cleland Atlanta VA Medical Center — Decatur
  • Henry Ford Hospital — Detroit
  • Minneapolis Heart Institute Foundation — Minneapolis
  • Oklahoma Heart Hospital — Oklahoma City

Publications

  • 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. PMID 34637140

Identifiers

NCT: NCT04077762 · REBIRTH

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗