Patients Indicated for a PICC for Any Medical Condition Clinical Trial
Official title:
A Randomized Prospective Multicenter Evaluation to Investigate the Incidence of Catheter Related Venous Thrombosis in Patients Undergoing Intravenous Therapy With the BioFlo™ Peripherally Inserted Central Catheter (PICC) or Bard® Dual-Lumen PowerPICC SOLO2®
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).
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