StudyFinder
The Radial vs. State-Of-The-Art FEmoral Access for Bleeding and Access SIte Complication Reduction in Cardiac CaTHeterization (REBIRTH) Trial
Status: Recruiting
The primary study objective is to evaluate whether radial access for cardiac catheterization of patients reduces vascular access complications and bleeding occurring within 72 h of the procedure or by hospital discharge, when compared with state-of-the-art femoral access. Patients randomized to femoral access will be further randomized to use of a micropuncture (21 gauge) vs. standard (18 gauge) needle.
Sex: Male or Female
Age: 18 years and over
Healthy Volunteers:
Inclusion Criteria:
• Age greater than 18 years
• Patients undergoing cardiac catheterization
• Has provided informed consent and agrees to participate
• Patients must be equally eligible to undergo cardiac catheterization via radial or femoral access
Exclusion Criteria:
• Patients arriving for emergency heart attack
• Patients undergoing only planned right heart catheterization, with no plan for concurrent left 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
Interventions:
Drug/Device: N/A
Conditions:
CAD, pre-op surgical evaluations, cardiac clearance, PCI, coronary stenosis
Keywords:
CAD, Cardiac Catheterizion, cardiac clearance, coronary stenosis, Femoral, PCI, Radial
Contact(s): Michelle Butcher - mbutche1@hfhs.org
Principal Investigator: Khaldoon Alaswad
Principal Investigator ID: kalaswa1@hfhs.org
Phase: N/A
See this study on ClinicalTrials.gov