Clinical trial NCT01033357: Safety Study of the Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access
Official title: A Long Term Safety Study of the Vascular Wrap(TM) Paclitaxel-Eluting Mesh After Surgical Implantation With the Lifespan® Graft in the Upper Extremity for Hemodialysis Vascular Access
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: End Stage Renal Failure on Dialysis
Hyperplasia
Keywords: dialysis
hemodialysis
neointimal hyperplasia
Lead sponsor: Angiotech Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-12-16
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: The purpose of this study is to determine whether the long term use of the experimental Vascular Wrap(TM) Paclitaxel-Eluting Mesh is safe in the treatment of subjects needing hemodialysis access (via an expanded polytetrafluoroethylene (ePTFE) graft).

Detailed description: The primary objective of this study is to determine long term safety of the Lifespan® ePTFE Vascular Graft and Vascular Wrap(TM) Paclitaxel-Eluting Mesh in comparison to the Lifespan® graft alone.

Eligibility criteria: Inclusion Criteria: To be considered for enrollment, subjects must:

* have been randomized in protocol 012-VWAV06;
* have signed and dated an IRB-approved written informed consent to participate in 012-VWAV06 as well as this study;
* be willing to comply with all aspects of the evaluation schedule over a period of 60 months post device insertion;
* allow representatives of the sponsor, designated Clinical Research Organization (CRO), Institutional Review Board (IRB), the Ethics Committee, and U.S. Food and Drug Administration (FDA) to review his/her relevant medical records.

Exclusion Criteria:

* Subjects who withdrew or were withdrawn from study 012-VWAV06.

Primary outcomes:
measure: Nature and incidence of Adverse Events between treatment groups clinical difference in product-related adverse events
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
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 Hospital
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: 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 Healthcare
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: Wauwatosa
country: United States
facility: The Wisconsin Heart Hospital
state: Wisconsin
Study officials:
affiliation: Angiotech Pharmaceuticals
name: Rui Avelar, M.D.
role: STUDY_CHAIR
References: