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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


N/A
18 Years
N/A
Not Enrolling
Both
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;
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.

Type of Study:

Interventional

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:

No

Principal Investigator

Rui Avelar, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Angiotech Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

012-VWAV06

NCT ID:

NCT00448708

Start Date:

March 2007

Completion Date:

April 2009

Related Keywords:

  • Kidney Diseases
  • ESRD
  • Hemodialysis Access
  • Kidney Diseases

Name

Location

Southern California Permanente Medical GroupDowney, California  90242
University Of Cincinnati Medical CenterCincinnati,, Ohio  45267-0589
Indiana UniversityIndianapolis, Indiana  46202
Biomedical Research Alliance of New YorkNew York, New York  10016
UCSD Medical CenterLa Jolla, California  92093
University of ToledoToledo, Ohio  43614
Baptist Cancer InstituteJacksonville, Florida  32207
San Francisco VA Medical CenterSan Francisco, California  94110
Texas Tech University Health Sciences CenterLubbock, Texas  79430
St. Luke's Roosevelt Hospital CenterNew York, New York  10019
Florida Research Network, LlcGainesville, Florida  32605
Thoracic And Cardiovascular Healthcare FoundationLansing, Michigan  48910
Clinical Research CenterBirmingham, Alabama  35213
Ladenheim, Inc.Fresno, California  93710
Centinela HospitalInglewood, California  90301
USC CVTI - Healthcare Consultation IILos Angeles, California  90033
National Institute of Clinical ResearchLos Angeles, California  90017
Jacksonville Center for Clincal ResearchJacksonville, Florida  32216
Discovery Medical Research GroupOcala, Florida  34471
Southeastern Urological Center, P.ATallahassee, Florida  32308
University of South Florida- Research FoundationTampa, Florida  33606
Cardiothoracic and Vascular Surgery AssociatesMacon, Georgia  31208
Renal Care AssociatesPeoria, Illinois  61603
Southern Illinois UniversitySpringfield, Illinois  62702
Washington County Hospital AssociationHagerstown, Maryland  21740
Michigan Vascular Research CenterFlint, Michigan  48507
BRANY - Montefiore Medical CenterBronx, New York  10467
Nephrology Associates P. C.Flushing, New York  11355
Rex HospitalRaleigh, North Carolina  27606
Clinical Research of Winston-Salem, Inc.Winston-Salem, North Carolina  27103
Health First Medical GroupFort Worth, Texas  76135
Peripheral Vascular AssociatesSan Antonio, Texas  78205
The Wisconsin Heart HospitalMilwaukee, Wisconsin  53217