NCT02685995

VectorFlow Tunneled Dialysis Catheter (TDC) Versus Palindrome TDC

Randomized Trial Comparing VectorFlow Tunneled Dialysis Catheter to Palindrome Tunneled Dialysis Catheter

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Randomized two-arm study examining 90 day primary patency of two FDA-approved tunneled dialysis catheters.

Detailed description

The VectorFlow tunneled dialysis catheter is a novel symmetrical tip design tunneled dialysis catheter which in pre-clinical testing and retrospective review has improved flow and patency compared to other dialysis catheter designs. This study will compare 90 day patency rates of newly inserted VF catheters to the Palindrome catheter both of which are FDA approved devices and will inserted as standard of care. The Palindrome catheter has been selected as the comparison device because it is also a symmetrical tip catheter design and prior studies by the manufacturer of this device suggests it has a lower occlusion rate and better flow compared to other catheter designs.

Conditions

• Renal Failure Chronic Requiring Hemodialysis
• Chronic Renal Insufficiency

Interventions

Type	Name	Description
DEVICE	VectorFlow TDC	TDC insertion with VectorFlow will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol. Following TDC insertion, the catheter may be used immediately. The goal of HD is typically to achieve a target effective blood flow of 300mL/min within the first 3 hemodialysis sessions. The dialysis records from each of the first three HD sessions will be reviewed by the study coordinator for (A) Blood flow rate (QB), (B) Arterial and venous lumen pressures, (C) Kt/V, and (D) Urea reduction ratio (URR). Additionally, need and use of thrombolytic infusion (ie t-PA) (other than single dose injection) to restore or improve patency and/or need for catheter exchange.
DEVICE	Palindrome TDC	TDC insertion with Palindrome will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol. Following TDC insertion, the catheter may be used immediately. The goal of HD is typically to achieve a target effective blood flow of 300mL/min within the first 3 hemodialysis sessions. The dialysis records from each of the first three HD sessions will be reviewed by the study coordinator for (A) Blood flow rate (QB), (B) Arterial and venous lumen pressures, (C) Kt/V, and (D) Urea reduction ratio (URR). Additionally, need and use of thrombolytic infusion (ie t-PA) (other than single dose injection) to restore or improve patency and/or need for catheter exchange.

Timeline

• Start date: 2015-12-01
• Primary completion: 2019-12-01
• Completion: 2020-07-01
• First posted: 2016-02-19
• Last updated: 2021-02-08
• Results posted: 2021-02-08

Locations

2 sites across 1 country: United States