Clinical trial NCT00448708: Safety and Efficacy of Angiotech Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Kidney Diseases
ESRD
Keywords: Hemodialysis Access
Lead sponsor: Angiotech Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-03-19
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Time-to-loss of Target Site Primary Patency
timeFrame: 1 year
Secondary outcomes:
measure: Adverse Events
timeFrame: 1 year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center
state: Alabama
city: Fresno
country: United States
facility: Ladenheim, Inc.
state: California
city: Inglewood
country: United States
facility: Centinela Hospital
state: California
city: Los Angeles
country: United States
facility: National Institute of Clinical Research
state: California
city: Los Angeles
country: United States
facility: USC CVTI - Healthcare Consultation II
state: California
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
city: San Diego
country: United States
facility: Southern California Permanente Medical Group
state: California
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
city: Gainsville
country: United States
facility: Florida Research Network, LLC
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clincal Research
state: Florida
city: Ocala
country: United States
facility: Discovery Medical Research Group
state: Florida
city: Pensacola
country: United States
facility: Baptist Cancer Institute
state: Florida
city: Tallahassee
country: United States
facility: Southeastern Urological Center, P.A
state: Florida
city: Tampa
country: United States
facility: University of South Florida- Research Foundation
state: Florida
city: Macon
country: United States
facility: Cardiothoracic and Vascular Surgery Associates
state: Georgia
city: Peoria
country: United States
facility: Renal Care Associates
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Hagerstown
country: United States
facility: Washington County Hospital Association
state: Maryland
city: Flint
country: United States
facility: Michigan Vascular Research Center
state: Michigan
city: Lansing
country: United States
facility: Thoracic and Cardiovascular Healthcare Foundation
state: Michigan
city: Bronx
country: United States
facility: Biomedical Research Alliance of New York
state: New York
city: Bronx
country: United States
facility: BRANY - Montefiore Medical Center
state: New York
city: Flushing
country: United States
facility: Nephrology Associates P. C.
state: New York
city: New York
country: United States
facility: St. Luke's Roosevelt Hospital Center
state: New York
city: Raleigh
country: United States
facility: Rex Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Clinical Research of Winston-Salem, Inc.
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Toledo
country: United States
facility: University of Toledo
state: Ohio
city: Fort Worth
country: United States
facility: Health First Medical Group
state: Texas
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
city: San Antonio
country: United States
facility: Peripheral Vascular Associates
state: Texas
city: Milwaukee
country: United States
facility: The Wisconsin Heart Hospital
state: Wisconsin
Study officials:
affiliation: Angiotech Pharmaceuticals
name: Rui Avelar, MD
role: STUDY_CHAIR
References: