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

Not Applicable

Terminated

• Conditions: Kidney Diseases; ESRD

• Registration Number: NCT00448708
• Lead Sponsor: Angiotech Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-03-15
• Study First Submitted QC: 2007-03-15
• Study First Posted: 2007-03-19
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Results First Submitted: 2011-06-08
• Status Verified: 2011-10
• Results First Submitted QC: 2011-10-13
• Last Update Submitted: 2011-10-13
• Results First Posted: 2011-11-17
• Last Update Posted: 2011-11-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 222

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time-to-loss of Target Site Primary Patency	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	1 year	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.

Trial Locations

Locations (33)

Clinical Research Center; 🇺🇸 Birmingham, Alabama, United States

Ladenheim, Inc.; 🇺🇸 Fresno, California, United States

Centinela Hospital; 🇺🇸 Inglewood, California, United States

National Institute of Clinical Research; 🇺🇸 Los Angeles, California, United States

USC CVTI - Healthcare Consultation II; 🇺🇸 Los Angeles, California, United States

UCSD Medical Center; 🇺🇸 San Diego, California, United States

Southern California Permanente Medical Group; 🇺🇸 San Diego, California, United States

San Francisco VA Medical Center; 🇺🇸 San Francisco, California, United States

Florida Research Network, LLC; 🇺🇸 Gainsville, Florida, United States

Jacksonville Center for Clincal Research; 🇺🇸 Jacksonville, Florida, United States

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