RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-11-15
Study Completion:2028-08-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04077762

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years and older
  2. * Undergoing diagnostic angiography for ischemic symptoms with possible PCI, or undergoing planned urgent or elective PCI
  3. * Has provided informed consent and agrees to participate
  4. * Patients must be equally eligible to undergo cardiac catheterization via radial or femoral access
  1. * Primary PCI for STEMI
  2. * Planned right heart catheterization
  3. * Valvular heart disease requiring valve surgery within 30 days after the index procedure
  4. * 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)
  5. * Peripheral arterial disease prohibiting vascular access
  6. * Presence of bilateral internal mammary artery coronary bypass grafts
  7. * 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
  8. * Planned staged PCI within 30 days after index procedure.
  9. * Any planned surgeries within 30 days after index procedure
  10. * Planned dual arterial access (for example for chronic total occlusion PCI)
  11. * Coexisting conditions that limit life expectancy to less than 30 days
  12. * Positive pregnancy test

Contacts and Locations

Study Contact

Bavana Rangan, BDS, MPH, CCRP
CONTACT
612-863-3852
bavana.rangan@allina.com
Olga Mastrodemos
CONTACT
olga.mastrodemos@allina.com

Principal Investigator

Emmanouil Brilakis, MD, PhD
PRINCIPAL_INVESTIGATOR
Minneapolis Heart Institute Foundation

Study Locations (Sites)

San Francisco VA Medical Center
San Francisco, California, 94121
United States
Mayo Clinic Florida
Jacksonville, Florida, 32224
United States
Joseph Maxwell Cleland Atlanta VA Medical Center
Decatur, Georgia, 30033
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120
United States

Collaborators and Investigators

Sponsor: Minneapolis Heart Institute Foundation

  • Emmanouil Brilakis, MD, PhD, PRINCIPAL_INVESTIGATOR, Minneapolis Heart Institute Foundation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-11-15
Study Completion Date2028-08-19

Study Record Updates

Study Start Date2019-11-15
Study Completion Date2028-08-19

Terms related to this study

Additional Relevant MeSH Terms

  • Patient Satisfaction
  • Vascular Access Complication