Safety Study of the Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access

End Stage Renal Failure on Dialysis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01033357
• Other study ID #: 014-VWAV07
• Status: Terminated
• Phase: N/A
• First received: December 15, 2009
• Last updated: February 7, 2013
• Start date: March 2008
• Est. completion date: October 2010

Study information

• Verified date: February 2013
• Source: Angiotech Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 222
• Est. completion date: October 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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• Subjects who withdrew or were withdrawn from study 012-VWAV06.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Failure on Dialysis
• Hyperplasia
• Kidney Failure, Chronic

Intervention

Device:
• Graft, Vascular Wrap
Lifespan® ePTFE Vascular Graft and Vascular Wrap Paclitaxel-Eluting Mesh (0.9 µg/mm2 paclitaxel)
• Lifespan® ePTFE Vascular Graft Only
Vascular Graft only

Locations

Country	Name	City	State
United States	BRANY - Montefiore Medical Center	Bronx	New York
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	Michigan Vascular Research Center	Flint	Michigan
United States	Nephrology Associates P. C.	Flushing	New York
United States	Health First Medical Group	Fort Worth	Texas
United States	Ladenheim, Inc.	Fresno	California
United States	Florida Research Network, LLC	Gainsville	Florida
United States	Washington County Hospital Association	Hagerstown	Maryland
United States	Indiana University	Indianapolis	Indiana
United States	Centinela Hospital	Inglewood	California
United States	Jacksonville Center for Clincal Research	Jacksonville	Florida
United States	Thoracic and Cardiovascular Healthcare Foundation	Lansing	Michigan
United States	National Institute of Clinical Research	Los Angeles	California
United States	USC CVTI - Healthcare Consultation II	Los Angeles	California
United States	Texas Tech University Health Sciences Center	Lubbock	Texas
United States	Cardiothoracic and Vascular Surgery Associates	Macon	Georgia
United States	St. Luke's Roosevelt Hospital Center	New York	New York
United States	Discovery Medical Research Group	Ocala	Florida
United States	Baptist Hospital	Pensacola	Florida
United States	Renal Care Associates	Peoria	Illinois
United States	Rex Healthcare	Raleigh	North Carolina
United States	Peripheral Vascular Associates	San Antonio	Texas
United States	Southern California Permanente Medical Group	San Diego	California
United States	UCSD Medical Center	San Diego	California
United States	San Francisco VA Medical Center	San Francisco	California
United States	Southern Illinois University	Springfield	Illinois
United States	University of South Florida- Research Foundation	Tampa	Florida
United States	University of Toledo	Toledo	Ohio
United States	The Wisconsin Heart Hospital	Wauwatosa	Wisconsin
United States	Clinical Research of Winston-Salem, Inc.	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Angiotech Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nature and incidence of Adverse Events between treatment groups clinical difference in product-related adverse events		4 years	Yes