VectorFlow Tunneled Dialysis Catheter (TDC) Versus Palindrome TDC

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

December 31, 2019

Study Completion Date

July 31, 2020

Conditions
Renal Failure Chronic Requiring HemodialysisChronic Renal Insufficiency
Interventions
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.

Trial Locations (2)

19104

Hospital of the Unviersity of Pennsylvania, Philadelphia

Penn Presbyterian Medical Center, Philadelphia

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Teleflex

INDUSTRY

collaborator

Arrow International

INDUSTRY

lead

University of Pennsylvania

OTHER

NCT02685995 - VectorFlow Tunneled Dialysis Catheter (TDC) Versus Palindrome TDC | Biotech Hunter | Biotech Hunter