The PROOF Study: The PICC Related Obstruction Of Flow Study

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).

Inclusion Criteria:

1. Is indicated for a PICC based on institutional practices
2. Is ≥ 18 years of age
3. Is expected to require use of a PICC for a minimum of 10 days
4. Has normal findings on initial ultrasonography (complete Ultrasound Checklist)
5. Vein used for PICC placement must be a minimum of 5mm in diameter
6. Is able to comprehend and have signed the Informed Consent Form (ICF) to participate in the study (or has the ICF signed by the patient's legal representative)

Exclusion Criteria:

1. Anticipates or has presence of dialysis grafts or other ipsilateral intraluminal devices, including pacemakers (with the exception of peripheral IV catheters)

2. Has current or anticipated hematologic derangements, including:

   • thrombocytopenia
   • history of heparin-induced thrombocytopenia
   • coagulopathy (International Normalized Ratio 2.5 or greater)
   • established diagnosis of hypercoagulable syndrome (e.g., protein C and S deficiency, anti-phospholipid antibody or polycythemia) or requires systemic therapeutic anticoagulation (Note: The following prophylactic treatments are allowed: subcutaneous heparin or enoxaparin sodium injection, and concomitant use of platelet aggregation inhibitors, e.g., Plavix/Ticlid/aspirin)

3. Has central veno-occlusive disease

4. Has history of previous catheter-related thrombosis

5. Has arm identified for catheterization that exhibits any of the following (and the contralateral arm is also unsuitable for PICC placement based on the same criteria):

   • Current (or prior history of) venous thrombosis in all or any portion of the vein where the catheter is expected to reside
   • Conditions that impede venous return from the extremity (such as paralysis or lymphedema after mastectomy)
   • Pre-existing skin surface or subsurface infection at or near the proposed catheter insertion site
   • Anatomical distortions from surgery, injury or trauma (e.g., orthopedic conditions such as compound fractures requiring reconstructive procedures)
   • Anatomical irregularities (structural, vascular, neurological) which may compromise catheter insertion or catheter care procedures in the involved extremity (e.g., reflex sympathetic dystrophy)

6. Is pregnant or lactating

7. Has been previously enrolled in this clinical study, or is participating in another clinical study that is contraindicative to the treatment or outcomes of this investigation