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

Trial to Assess the Effectiveness of Maintaining Patency and Safety of the Vascular Wrap Paclitaxel-Eluting Mesh After Surgical Implantation With the Lifespan® ePTFE Vascular Graft in the Upper Extremity for Hemodialysis Vascular Access

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

Study Overview

• Status: Terminated
• Conditions: Kidney Diseases; ESRD
• Intervention / Treatment: Device: Vascular Wrap Paclitaxel-Eluting Mesh; Device: Lifespan® ePTFE Vascular Graft

• Study Type: Interventional
• Enrollment (Actual): 222
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35213
      • Clinical Research Center
  • California
    • Fresno, California, United States, 93710
      • Ladenheim, Inc.
    • Inglewood, California, United States, 90301
      • Centinela Hospital
    • Los Angeles, California, United States, 90017
      • National Institute of Clinical Research
    • Los Angeles, California, United States, 90033
      • USC CVTI - Healthcare Consultation II
    • San Diego, California, United States, 92120
      • Southern California Permanente Medical Group
    • San Diego, California, United States, 92109
      • UCSD Medical Center
    • San Francisco, California, United States, 94121
      • San Francisco VA Medical Center
  • Florida
    • Gainsville, Florida, United States, 32605
      • Florida Research Network, LLC
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clincal Research
    • Ocala, Florida, United States, 34471
      • Discovery Medical Research Group
    • Pensacola, Florida, United States, 32501
      • Baptist Cancer Institute
    • Tallahassee, Florida, United States, 32308
      • Southeastern Urological Center, P.A
    • Tampa, Florida, United States, 33606
      • University of South Florida- Research Foundation
  • Georgia
    • Macon, Georgia, United States, 31208
      • Cardiothoracic and Vascular Surgery Associates
  • Illinois
    • Peoria, Illinois, United States, 61603
      • Renal Care Associates
    • Springfield, Illinois, United States, 62702
      • Southern Illinois University
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Maryland
    • Hagerstown, Maryland, United States, 21740
      • Washington County Hospital Association
  • Michigan
    • Flint, Michigan, United States, 48507
      • Michigan Vascular Research Center
    • Lansing, Michigan, United States, 48910
      • Thoracic And Cardiovascular Healthcare Foundation
  • New York
    • Bronx, New York, United States, 10461
      • Biomedical Research Alliance Of New York
    • Bronx, New York, United States, 10467
      • BRANY - Montefiore Medical Center
    • Flushing, New York, United States, 11355
      • Nephrology Associates P. C.
    • New York, New York, United States, 10025
      • St. Luke's Roosevelt Hospital Center
  • North Carolina
    • Raleigh, North Carolina, United States, 27606
      • Rex Hospital
    • Winston-Salem, North Carolina, United States, 27103
      • Clinical Research of Winston-Salem, Inc.
  • Ohio
    • Cincinnati, Ohio, United States, 45206
      • University of Cincinnati Medical Center
    • Toledo, Ohio, United States, 43615
      • University of Toledo
  • Texas
    • Fort Worth, Texas, United States, 76135
      • Health First Medical Group
    • Lubbock, Texas, United States, 79430
      • Texas Tech University Health Sciences Center
    • San Antonio, Texas, United States, 78205
      • Peripheral Vascular Associates
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53217
      • The Wisconsin Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. be ≥ 18 years of age;
2. if female of childbearing potential, provide evidence of a negative pregnancy test within 3 days prior to graft placement (Day -3 to Day 0);
3. be a candidate for a new end-to-side arteriovenous anastomosis graft placed in the upper extremity;
4. have an outflow vein of greater than or equal to 3 mm in diameter;
5. be able to effectively communicate with study personnel;
6. be considered by the physician to be available for subsequent visits;
7. be willing to comply with all aspects of the treatment and evaluation schedule over a 52 week duration;
8. 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;
9. sign and date an IRB-approved written informed consent prior to initiation of any study procedures, including screening procedures;
10. 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
11. have the Lifespan® ePTFE Vascular Graft successfully implanted.

Exclusion Criteria:

1. 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;
2. 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;
3. a central venous stenosis on the ipsilateral side is documented;
4. a hypercoagulable state is documented;
5. life expectancy is less than one year;
6. an organ transplant is expected within 6 months of test or control product (study products) placement;
7. hypersensitivity to any component of the study products or procedural materials or medications is known;
8. concurrently involved in another investigational study;
9. a study product being investigated by others has been received within 30 days prior to randomization in this trial;
10. the study product being studied in this trial has previously been received;
11. uncontrolled hypertension with systolic BP >200mmHg or diastolic BP >115mmHg is present at screening;
12. currently receiving chemotherapy or radiation therapy; or
13. placement of a new end-to-end arteriovenous anastomosis graft is required.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vascular Wrap and 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.	Device: Vascular Wrap Paclitaxel-Eluting Mesh; 0.9 µg/mm^2 paclitaxel; Other Names: Vascular Wrap; paclitaxel mesh; Device: Lifespan® ePTFE Vascular Graft; vascular graft
No Intervention: 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.	Device: Lifespan® ePTFE Vascular Graft; vascular graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-to-loss of Target Site Primary Patency	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	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.	1 year

Collaborators and Investigators

• Sponsor: Angiotech Pharmaceuticals
• Investigators: Study Chair: Rui Avelar, MD, Angiotech Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: March 15, 2007
• First Submitted That Met QC Criteria: March 15, 2007
• First Posted (Estimate): March 19, 2007

Study Record Updates

• Last Update Posted (Estimate): November 17, 2011
• Last Update Submitted That Met QC Criteria: October 13, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Hemodialysis Access
• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Albumin-Bound Paclitaxel
• Other Study ID Numbers: 012-VWAV06