Propaten Randomized Investigation on Cost-benefit and Efficacy

NCT01601873 | Terminated Results DMC FDA Device

• 2 other identifiers: CTVS-KC01UTHSCMS-12/0095
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose for this study is to evaluate the patency and outcomes of conventional and heparin anticoagulant bonded arteriovenous grafts in patients with end stage renal disease.

Conditions

End-stage Renal Disease

Keywords

Arteriovenous graft; Propaten; Heparin-bonded; hemodialysis vascular access; Surgical; Arteriovenous Shunt

Outcome Measures

Primary Outcomes (6)

• Primary Graft Patency Rate

  Primary graft patency refers to the successful use of a vascular access for hemodialysis without any surgical or endovascular intervention.

  12 months

• Primary-Assisted Graft Patency Rate

  Primary-assisted graft patency is defined as a patent access with evidence of malfunction that requires an open surgical or endovascular intervention.

  12 months

• Secondary Graft Patency Rate

  Secondary graft patency is defined as a functional access following intervention for thrombosis or after any interposition grafting for any reason including stenosis, aneurysm or pseudoaneurysm.

  12 months

• Primary Graft Patency Rate

  Primary graft patency refers to the successful use of a vascular access for hemodialysis without any surgical or endovascular intervention.

  24 months after graft placement

• Primary-Assisted Graft Patency Rate

  Primary-assisted graft patency is defined as a patent access with evidence of malfunction that requires an open surgical or endovascular intervention.

  24 months after graft placement

• Secondary Graft Patency Rate

  Secondary graft patency is defined as a functional access following intervention for thrombosis or after any interposition grafting for any reason including stenosis, aneurysm or pseudoaneurysm.

  24 months after graft placement

Secondary Outcomes (4)

• Number of Participants With Complications or Morbidity Attributable to the Study

  at least 1 year but up to two years

• Cost Estimation and Analysis

  During the study period based on an average participant follow-up of 2 years after graft placement

• Quality of Life (QoL) Comparison

  Participants would be followed for a period of 2 years after graft placement

• Number of Postoperative Re-interventions

  at least 1 year but up to two years

Study Arms (2)

PROPATEN

EXPERIMENTAL

patients with heparin-bonded graft implantation

Device: PROPATEN

Standard Graft

ACTIVE COMPARATOR

patients undergoing ePTFE hemodialysis graft implantation

Device: Standard Graft

Interventions

PROPATEN DEVICE

Heparin-bonded graft implantation for hemodialysis vascular access

Also known as: Heparin-bonded hemodialysis graft

PROPATEN

Standard Graft DEVICE

non-heparin bonded conventional hemodialysis vascular access graft

Also known as: Conventional ePTFE hemodialysis graft

Standard Graft

Eligibility Criteria

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

You may qualify if:

• Aged ≥18 years of all ethnicities
• End-stage Renal Disease stage 4 (GFR 15-29 ml/min 1.73m2) or stage 5 (GFR \<15ml/min 1.73m2) per National Kidney Foundation guidelines
• Currently undergoing hemodialysis with a failure of previous access
• Expected to undergo hemodialysis within 6 months of presentation

You may not qualify if:

• Unable/refuse to abide with follow-up
• Known hypercoagulability syndrome or a bleeding disorder
• On a previous anticoagulant treatment
• Intraoperative decision in favor of fistula instead of graft
• Pregnant or breast-feeding women
• A documented history of heparin induced thrombocytopenia or allergy
• Active infections
• Evidence or suspicion of central vein stenosis

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• University Hospitals Cleveland Medical Center: collaborator
• University of Arkansas: collaborator
• Ochsner Health System: collaborator

Study Sites (5)

University of Arkansas for Medical Sciences (UAMS) & Central Arkansas Veterans Healthcare System (CAVHS)

Little Rock, Arkansas, 72205, United States

Location

John Ochsner Heart & Vascular Institute Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Department of Cardiothoracic and Vascular Surgery and Memorial Hermann Heart and Vascular Institute - Texas Medical Center

Houston, Texas, 77030, United States

Location

Department of Cardiothoracic and Vascular Surgery; Memorial Hermann Hospital Southeast

Houston, Texas, 77089, United States

Location

Related Publications (1)

• Charlton-Ouw KM, Nosrati N, Miller CC 3rd, Coogan SM, Safi HJ, Azizzadeh A. Outcomes of arteriovenous fistulae compared with heparin-bonded and conventional grafts for hemodialysis access. J Vasc Access. 2012 Apr-Jun;13(2):163-7. doi: 10.5301/JVA.2011.8715.

  PMID: 21983827 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; 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; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical

Limitations and Caveats

The trial was stopped early for futility based on a pre-planned interim analysis and a Bayesian probability forecast incorporating all available information from a recent meta-analysis.

Results Point of Contact

• Title: Kristofer Charlton-Ouw, MD
• Organization: The University of Texas Health Science Center at Houston

Kristofer.CharltonOuw@uth.tmc.edu

(713) 486-5117

Study Officials

• Kristofer M Charlton-Ouw, MD

  University of Texas Health Science Center, UT Medical School Department of Cardiothoracic and Vascular Surgery, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Cardiothoracic and Vascular Surgery

Study Record Dates

• First Submitted: May 16, 2012
• First Posted: May 18, 2012
• Study Start: November 9, 2012
• Primary Completion: December 31, 2017
• Study Completion: June 30, 2018
• Last Updated: February 27, 2019
• Results First Posted: February 27, 2019

Record last verified: 2019-01

Locations

US (5)