The main purpose of this study is to confirm whether the AngioDynamics BioFlo™ Peripherally Inserted Central Catheter (PICC) is associated with less formation of blood clots compared to another commercially available PICC.
Purpose: To investigate whether the BioFlo™ PICC will be associated with a reduced incidence of catheter-related venous thrombosis (including both symptomatic and asymptomatic) compared to another commercially available PICC: the Bard® PowerPICC SOLO2® Design: This is a randomized, multi-center clinical study. The study is designed as a two-arm prospectively controlled trial. Participants will be randomly assigned to either the study or control catheter using a 1:1 schema. Enrollment: Four hundred sixteen (416) patients will be enrolled at four (4) to eight (8) study sites in order to obtain 354 evaluable patients. Study Objectives: The primary objective of this study is to investigate the incidence of catheter-related venous thrombosis in patients receiving either the 5 Fr BioFlo™ PICC catheter or the control catheter, i.e., the 5 Fr Dual-Lumen PowerPICC SOLO2® catheter. Secondary objectives of this study are to investigate: * Incidence of other catheter-related complications, inclusive of catheter occlusion, catheter-related infection, technical failures, and premature catheter removals * Incidence of catheter occlusion (independently from other catheter-related complications) Additionally, economic outcomes with respect to medical resource utilization requirements will be compared between the two catheter groups (at US sites only).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
57
University of Miami Hospital
Miami, Florida, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
University of Louisville/Norton Hospital
Louisville, Kentucky, United States
Ottawa Hospital
Ottawa, Ontario, Canada
Incidence of Catheter-related Venous Thrombosis as Confirmed by Diagnostic Ultrasound
Time frame: 10 (+/-3) days and any time there is clinically suspected venous thrombosis (as per standard of care)
Incidence of Other Catheter-related Complications
Secondary objectives of this study are to investigate: * Incidence of other catheter-related complications, inclusive of catheter occlusion, catheter-related infection, technical failures, and premature catheter removals * Incidence of catheter occlusion (independently from other catheter-related complications)
Time frame: Up to 30 days post-insertion
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Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Switzerland