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

This study has been terminated.
(Imbalance in the # graft infections between the tx's (graft vs. graft + wrap))
Sponsor:
Information provided by (Responsible Party):
Angiotech Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01033357
First received: December 15, 2009
Last updated: February 7, 2013
Last verified: February 2013
  Purpose

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).


Condition Intervention
End Stage Renal Failure on Dialysis
Hyperplasia
Device: Graft, Vascular Wrap
Device: Lifespan® ePTFE Vascular Graft Only

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

Resource links provided by NLM:


Further study details as provided by Angiotech Pharmaceuticals:

Primary Outcome Measures:
  • Nature and incidence of Adverse Events between treatment groups clinical difference in product-related adverse events [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Enrollment: 222
Study Start Date: March 2008
Study Completion Date: October 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Graft, Vascular Wrap
Lifespan® ePTFE Vascular Graft and Vascular Wrap Paclitaxel-Eluting Mesh (0.9 µg/mm2 paclitaxel)
Device: Graft, Vascular Wrap
Lifespan® ePTFE Vascular Graft and Vascular Wrap Paclitaxel-Eluting Mesh (0.9 µg/mm2 paclitaxel)
Other Name: Vascular Wrap
Placebo Comparator: Graft
Lifespan® ePTFE Vascular Graft Only
Device: Lifespan® ePTFE Vascular Graft Only
Vascular Graft only

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01033357

  Show 30 Study Locations
Sponsors and Collaborators
Angiotech Pharmaceuticals
Investigators
Study Chair: Rui Avelar, M.D. Angiotech Pharmaceuticals
  More Information

No publications provided

Responsible Party: Angiotech Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01033357     History of Changes
Other Study ID Numbers: 014-VWAV07
Study First Received: December 15, 2009
Last Updated: February 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Angiotech Pharmaceuticals:
dialysis
hemodialysis
neointimal hyperplasia

Additional relevant MeSH terms:
Renal Insufficiency
Hyperplasia
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Pathologic Processes
Renal Insufficiency, Chronic
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014