VectorFlow Tunneled Dialysis Catheter (TDC) Versus Palindrome TDC

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT02685995
• Collaborator: Teleflex (Industry), Arrow International (Industry)
• Enrollment: 100
• Locations: 2
• Arms: 2
• Actual Duration (Months): 55
• Patients Per Site: 50
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Renal Failure Chronic Requiring Hemodialysis; Chronic Renal Insufficiency	Device: VectorFlow TDC; Device: Palindrome TDC	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Randomized Trial Comparing VectorFlow Tunneled Dialysis Catheter to Palindrome Tunneled Dialysis Catheter
• Actual Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Dec 1, 2019
• Actual Study Completion Date: Jul 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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.; Other Names: Palindrome™ Dialysis Catheter
Active Comparator: 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: 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.; Other Names: ARROW-Clark™ VectorFlow™ Hemodialysis Catheter

Outcome Measures

Primary Outcome Measures

1. Primary Patency - Intervention-free Interval (Measured in Weeks) [30, 60 and 90 days]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• End stage renal disease or acute renal failure requiring hemodialysis through a tunneled dialysis catheter

• Age >18, Age <80

• Capable of giving informed consent

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital of the Unviersity of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
2	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania
• Teleflex
• Arrow International

Investigators

• Principal Investigator: Gregory Nadolski, MD, University of Pennsylvania

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Aug 10, 2018

More Information

Additional Information:

• Vectorlow Dialysis Catheter Product Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT02685995
• Other Study ID Numbers: 823055
• First Posted: Feb 19, 2016
• Last Update Posted: Feb 8, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic

Study Results

Participant Flow

Arm/Group Title	Palindrome TDC	VectorFlow TDC
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	50	50
COMPLETED	49	49
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Palindrome TDC	VectorFlow TDC	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	50	50	100
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	57	59	58
Sex: Female, Male (Count of Participants)
Female	20 40%	26 52%	46 46%
Male	30 60%	24 48%	54 54%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	50 100%	50 100%	100 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	50 100%	50 100%	100 100%

Outcome Measures

1. Primary Outcome

Title	Primary Patency - Intervention-free Interval (Measured in Weeks)
Description	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.
Time Frame	30, 60 and 90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Palindrome TDC	VectorFlow TDC
Arm/Group Description	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.	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.
Measure Participants	49	49
30 Days	89.1 (6.2)	95.5 (3.3)
60 Days	79.4 (10.0)	87.2 (7.3)
90 days	71.5 (12.6)	80.6 (9.8)

Adverse Events

Time Frame	90 days from enrollment
Adverse Event Reporting Description	No adverse events occurred in this study
Arm/Group Title	Palindrome TDC		VectorFlow TDC
Arm/Group Description	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.		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.
All Cause Mortality
	Palindrome TDC		VectorFlow TDC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)
Serious Adverse Events
	Palindrome TDC		VectorFlow TDC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)
Other (Not Including Serious) Adverse Events
	Palindrome TDC		VectorFlow TDC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.