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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

18 Years
Not Enrolling
Kidney Diseases, ESRD

Thank you

Trial Information

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

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;

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Time-to-loss of Target Site Primary Patency

Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Rui Avelar, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Angiotech Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

March 2007

Completion Date:

April 2009

Related Keywords:

  • Kidney Diseases
  • ESRD
  • Hemodialysis Access
  • Kidney Diseases



Southern California Permanente Medical Group Downey, California  90242
University Of Cincinnati Medical Center Cincinnati,, Ohio  45267-0589
Indiana University Indianapolis, Indiana  46202
Biomedical Research Alliance of New York New York, New York  10016
UCSD Medical Center La Jolla, California  92093
University of Toledo Toledo, Ohio  43614
Baptist Cancer Institute Jacksonville, Florida  32207
San Francisco VA Medical Center San Francisco, California  94110
Texas Tech University Health Sciences Center Lubbock, Texas  79430
St. Luke's Roosevelt Hospital Center New York, New York  10019
Florida Research Network, Llc Gainesville, Florida  32605
Thoracic And Cardiovascular Healthcare Foundation Lansing, Michigan  48910
Clinical Research Center Birmingham, Alabama  35213
Ladenheim, Inc. Fresno, California  93710
Centinela Hospital Inglewood, California  90301
USC CVTI - Healthcare Consultation II Los Angeles, California  90033
National Institute of Clinical Research Los Angeles, California  90017
Jacksonville Center for Clincal Research Jacksonville, Florida  32216
Discovery Medical Research Group Ocala, Florida  34471
Southeastern Urological Center, P.A Tallahassee, Florida  32308
University of South Florida- Research Foundation Tampa, Florida  33606
Cardiothoracic and Vascular Surgery Associates Macon, Georgia  31208
Renal Care Associates Peoria, Illinois  61603
Southern Illinois University Springfield, Illinois  62702
Washington County Hospital Association Hagerstown, Maryland  21740
Michigan Vascular Research Center Flint, Michigan  48507
BRANY - Montefiore Medical Center Bronx, New York  10467
Nephrology Associates P. C. Flushing, New York  11355
Rex Hospital Raleigh, North Carolina  27606
Clinical Research of Winston-Salem, Inc. Winston-Salem, North Carolina  27103
Health First Medical Group Fort Worth, Texas  76135
Peripheral Vascular Associates San Antonio, Texas  78205
The Wisconsin Heart Hospital Milwaukee, Wisconsin  53217