Status:
TERMINATED
Safety and Efficacy of Angiotech Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access
Lead Sponsor:
Angiotech Pharmaceuticals
Conditions:
Kidney Diseases
ESRD
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT00448708
Start Date
March 1 2007
End Date
April 1 2009
Last Update
November 17 2011
Active Locations (33)
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1
Clinical Research Center
Birmingham, Alabama, United States, 35213
2
Ladenheim, Inc.
Fresno, California, United States, 93710
3
Centinela Hospital
Inglewood, California, United States, 90301
4
National Institute of Clinical Research
Los Angeles, California, United States, 90017