Safety and Efficacy of Angiotech Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access

Not Applicable

Terminated

Conditions: Kidney Diseases
ESRD

Interventions: Device: Vascular Wrap Paclitaxel-Eluting Mesh
Device: Lifespan® ePTFE Vascular Graft

Registration Number: NCT00448708

Lead Sponsor: Angiotech Pharmaceuticals

Brief Summary: This is a multi-center clinical study in subjects requiring arteriovenous grafts in the upper extremity for hemodialysis access. All subjects will provide informed consent before undergoing any study procedures. The study will consist of multiple subject visits and telephone contacts during the 52 week study period. During the study period subjects must also maintain an appropriate hemodialysis schedule.

IDE Number: G060250

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 222

Inclusion Criteria

be ≥ 18 years of age;
if female of childbearing potential, provide evidence of a negative pregnancy test within 3 days prior to graft placement (Day -3 to Day 0);
be a candidate for a new end-to-side arteriovenous anastomosis graft placed in the upper extremity;
have an outflow vein of greater than or equal to 3 mm in diameter;
be able to effectively communicate with study personnel;
be considered by the physician to be available for subsequent visits;
be willing to comply with all aspects of the treatment and evaluation schedule over a 52 week duration;
allow representatives of the sponsor, designated CRO, Institutional Review Board (IRB), the Ethics Committee, and U.S. Food and Drug Administration (FDA) to review his/her relevant medical records;
sign and date an IRB-approved written informed consent prior to initiation of any study procedures, including screening procedures;
must agree to participate in protocol 014-VWAV07, a safety study to run consecutively for an additional 4 years or until Post-Market Approval (PMA), whichever is longer; and
have the Lifespan® ePTFE Vascular Graft successfully implanted.

Exclusion Criteria

pregnant, breast-feeding, or female of childbearing potential who do not agree to remain abstinent or to use a contraceptive method during the study period. Non-childbearing potential is defined as either post-menopausal (amenorrheic for at least 1 year) or surgically sterile. Surgically sterile is defined as tubal ligation or the absence of the uterus and/or ovaries;
male of childbearing potential, who does not agree to remain abstinent or to use contraception to prevent fathering a child during the course of the study. Non-childbearing potential is defined as vasectomy or bilateral orchiectomy;
a central venous stenosis on the ipsilateral side is documented;
a hypercoagulable state is documented;
life expectancy is less than one year;
an organ transplant is expected within 6 months of test or control product (study products) placement;
hypersensitivity to any component of the study products or procedural materials or medications is known;
concurrently involved in another investigational study;
a study product being investigated by others has been received within 30 days prior to randomization in this trial;
the study product being studied in this trial has previously been received;
uncontrolled hypertension with systolic BP >200mmHg or diastolic BP >115mmHg is present at screening;
currently receiving chemotherapy or radiation therapy; or
placement of a new end-to-end arteriovenous anastomosis graft is required.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vascular Wrap and Graft	Vascular Wrap Paclitaxel-Eluting Mesh	Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh: The Lifespan® ePTFE Vascular Graft is implanted as an arteriovenous graft in an upper extremity to provide a hemodialysis access. The Vascular WrapTM Paclitaxel-Eluting Mesh is positioned on the vein and placed around the venous anastomosis to include both the toe and the heel of the anastomosis, and is sutured in place.
Vascular Wrap and Graft	Lifespan® ePTFE Vascular Graft	Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh: The Lifespan® ePTFE Vascular Graft is implanted as an arteriovenous graft in an upper extremity to provide a hemodialysis access. The Vascular WrapTM Paclitaxel-Eluting Mesh is positioned on the vein and placed around the venous anastomosis to include both the toe and the heel of the anastomosis, and is sutured in place.
Lifespan® ePTFE Vascular Graft	Lifespan® ePTFE Vascular Graft	Lifespan® ePTFE Vascular Graft Only: The Lifespan® ePTFE Vascular Graft is implanted as an arteriovenous graft in an upper extremity to provide a hemodialysis access.

Primary Outcome Measures

Name	Time	Method
Time-to-loss of Target Site Primary Patency	1 year	Subjects had primary patency at the target site from graft placement until an intervention on the target site occurred. The duration between graft implantation and graft abandonment due to loss of patency at the target site was the "time-to-loss of primary patency." Note: The study was halted early and therefore became underpowered to analyze efficacy as detailed in the protocol.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	1 year	adverse events with at least 5% incidence, reported as number of subjects experiencing the event (rather than total number of events). Adverse events were collected via subject querying at each visit and telephone contact, and by medical record review.

Trial Locations

Locations (33): Rex Hospital
🇺🇸
Raleigh, North Carolina, United States
UCSD Medical Center
🇺🇸
San Diego, California, United States
Southern California Permanente Medical Group
🇺🇸
San Diego, California, United States
University of Cincinnati Medical Center
🇺🇸
Cincinnati, Ohio, United States
Peripheral Vascular Associates
🇺🇸
San Antonio, Texas, United States
Centinela Hospital
🇺🇸
Inglewood, California, United States
Ladenheim, Inc.
🇺🇸
Fresno, California, United States
Jacksonville Center for Clincal Research
🇺🇸
Jacksonville, Florida, United States
National Institute of Clinical Research
🇺🇸
Los Angeles, California, United States
Cardiothoracic and Vascular Surgery Associates
🇺🇸
Macon, Georgia, United States
Washington County Hospital Association
🇺🇸
Hagerstown, Maryland, United States
Thoracic and Cardiovascular Healthcare Foundation
🇺🇸
Lansing, Michigan, United States
USC CVTI - Healthcare Consultation II
🇺🇸
Los Angeles, California, United States
Discovery Medical Research Group
🇺🇸
Ocala, Florida, United States
Nephrology Associates P. C.
🇺🇸
Flushing, New York, United States
Southeastern Urological Center, P.A
🇺🇸
Tallahassee, Florida, United States
Texas Tech University Health Sciences Center
🇺🇸
Lubbock, Texas, United States
Baptist Cancer Institute
🇺🇸
Pensacola, Florida, United States
Southern Illinois University
🇺🇸
Springfield, Illinois, United States
Indiana University
🇺🇸
Indianapolis, Indiana, United States
Clinical Research Center
🇺🇸
Birmingham, Alabama, United States
Florida Research Network, LLC
🇺🇸
Gainsville, Florida, United States
BRANY - Montefiore Medical Center
🇺🇸
Bronx, New York, United States
The Wisconsin Heart Hospital
🇺🇸
Milwaukee, Wisconsin, United States
San Francisco VA Medical Center
🇺🇸
San Francisco, California, United States
Michigan Vascular Research Center
🇺🇸
Flint, Michigan, United States
St. Luke's Roosevelt Hospital Center
🇺🇸
New York, New York, United States
Renal Care Associates
🇺🇸
Peoria, Illinois, United States
University of Toledo
🇺🇸
Toledo, Ohio, United States
Health First Medical Group
🇺🇸
Fort Worth, Texas, United States
University of South Florida- Research Foundation
🇺🇸
Tampa, Florida, United States
Biomedical Research Alliance of New York
🇺🇸
Bronx, New York, United States
Clinical Research of Winston-Salem, Inc.
🇺🇸
Winston-Salem, North Carolina, United States