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

This study has been terminated.
(Due to an imbalance in graft infections between groups.)
Sponsor:
Information provided by (Responsible Party):
Angiotech Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00448708
First received: March 15, 2007
Last updated: October 13, 2011
Last verified: October 2011
  Purpose

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


Condition Intervention
Kidney Diseases
ESRD
Device: Vascular Wrap Paclitaxel-Eluting Mesh
Device: Lifespan® ePTFE Vascular Graft

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Trial to Assess the Effectiveness of Maintaining Patency and Safety of the Vascular Wrap Paclitaxel-Eluting Mesh After Surgical Implantation With the Lifespan® ePTFE Vascular 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:
  • Time-to-loss of Target Site Primary Patency [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • Adverse Events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 222
Study Start Date: March 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vascular Wrap and Graft
Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh: The Lifespan® ePTFE Vascular Graft is implanted as an arteriovenous graft in an upper extremity to provide a hemodialysis access. The Vascular WrapTM Paclitaxel-Eluting Mesh is positioned on the vein and placed around the venous anastomosis to include both the toe and the heel of the anastomosis, and is sutured in place.
Device: Vascular Wrap Paclitaxel-Eluting Mesh
0.9 µg/mm^2 paclitaxel
Other Names:
  • Vascular Wrap
  • paclitaxel mesh
Device: Lifespan® ePTFE Vascular Graft
vascular graft
No Intervention: Lifespan® ePTFE Vascular Graft
Lifespan® ePTFE Vascular Graft Only: The Lifespan® ePTFE Vascular Graft is implanted as an arteriovenous graft in an upper extremity to provide a hemodialysis access.
Device: Lifespan® ePTFE Vascular Graft
vascular graft

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00448708

  Show 33 Study Locations
Sponsors and Collaborators
Angiotech Pharmaceuticals
Investigators
Study Chair: Rui Avelar, MD Angiotech Pharmaceuticals
  More Information

No publications provided

Responsible Party: Angiotech Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00448708     History of Changes
Other Study ID Numbers: 012-VWAV06
Study First Received: March 15, 2007
Results First Received: June 8, 2011
Last Updated: October 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Angiotech Pharmaceuticals:
Hemodialysis Access

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
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 August 19, 2014