VectorFlow Tunneled Dialysis Catheter (TDC) Versus Palindrome TDC

NCT02685995 | Completed Results DMC

• 1 other identifier: 823055
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Renal Failure Chronic Requiring Hemodialysis; Chronic Renal Insufficiency

Outcome Measures

Primary Outcomes (1)

• Primary Patency - Intervention-free Interval (Measured in Weeks)

  The primary study endpoint will be primary patency at 90 days following catheter insertion. Primary patency is defined as an HD catheter which provides adequate hemodialysis (flow \>300mL/min) without need for additional interventions (ie TPA infusions or catheter exchange) to maintain flow or correct device failure.

  30, 60 and 90 days

Study Arms (2)

Palindrome TDC

ACTIVE COMPARATOR

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.

Device: Palindrome TDC

VectorFlow TDC

ACTIVE COMPARATOR

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: VectorFlow TDC

Interventions

VectorFlow TDC DEVICE

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.

Also known as: ARROW-Clark™ VectorFlow™ Hemodialysis Catheter

VectorFlow TDC

Palindrome TDC DEVICE

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.

Also known as: Palindrome™ Dialysis Catheter

Palindrome TDC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• End stage renal disease or acute renal failure requiring hemodialysis through a tunneled dialysis catheter
• Age \>18, Age \<80
• Capable of giving informed consent

You may not qualify if:

• Coagulopathy defined as international normalized ration (INR) \>2 which cannot be corrected with fresh frozen plasma
• Platelet count \<50,000/microliter, which cannot be corrected with platelet transfusion
• Active skin infections at site of TDC insertion
• Presence of bacteremia or infected AVG/AVF within 7 days prior to enrollment
• Neutropenia defined as absolute neutrophil count less then 1,700/microliter
• Known central venous stenosis
• Occlusion of bilateral external and internal jugular veins or bilateral brachiocephalic veins or stenosis of the superior vena cava
• Functioning surgical HD access (ie AVG/AVF) or AVG/AVF which is expected to be functional within 90 days of enrollment
• Inability to provide informed consent
• Pregnant or nursing women
• In the event a physician does not feel that either catheter would be appropriate for a subject, the subject will not be eligible to participate

Sponsors & Collaborators

• University of Pennsylvania: lead
• Teleflex: collaborator
• Arrow International: collaborator

Study Sites (2)

Hospital of the Unviersity of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

• Vectorlow Dialysis Catheter Product Information

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Gregory Nadolski, MD
• Organization: University of Pennsylvania

gregory.nadolski@pennmedicine.upenn.edu

(215) 662-7892

Study Officials

• Gregory Nadolski, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2016
• First Posted: February 19, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: July 1, 2020
• Last Updated: February 8, 2021
• Results First Posted: February 8, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)