End Stage Renal Failure on DialysisNCT01033357
Safety Study of the Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access
A study testing Graft, Vascular Wrap and Lifespan® ePTFE Vascular Graft Only in people with End Stage Renal Failure on Dialysis and Hyperplasia, run by Angiotech Pharmaceuticals at 30 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Failure on Dialysis, Hyperplasia
- What is being tested?
- Graft, Vascular Wrap and Lifespan® ePTFE Vascular Graft Only
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 222 participants
- Where
- 30 sitesUnited States
- Study dates
- Mar 2008to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Subjects who withdrew or were withdrawn from study 012-VWAV06.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
Michigan Vascular Research Center
Flint, Michigan, 48507
Nephrology Associates P. C.
Flushing, New York, 11355
Health First Medical Group
Fort Worth, Texas, 76135
Ladenheim, Inc.
Fresno, California, 93710
Florida Research Network, LLC
Gainsville, Florida, 32605
Washington County Hospital Association
Hagerstown, Maryland, 21740
Indiana University
Indianapolis, Indiana, 46202
Centinela Hospital
Inglewood, California, 90301
Jacksonville Center for Clincal Research
Jacksonville, Florida, 32216
Thoracic and Cardiovascular Healthcare Foundation
Lansing, Michigan, 48910
National Institute of Clinical Research
Los Angeles, California, 90017
USC CVTI - Healthcare Consultation II
Los Angeles, California, 90033
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
Cardiothoracic and Vascular Surgery Associates
Macon, Georgia, 31208
St. Luke's Roosevelt Hospital Center
New York, New York, 10025
Discovery Medical Research Group
Ocala, Florida, 34471
Baptist Hospital
Pensacola, Florida, 32501
Renal Care Associates
Peoria, Illinois, 61603
Rex Healthcare
Raleigh, North Carolina, 27607
Peripheral Vascular Associates
San Antonio, Texas, 78205
UCSD Medical Center
San Diego, California, 92109
Southern California Permanente Medical Group
San Diego, California, 92120
San Francisco VA Medical Center
San Francisco, California, 94121
Southern Illinois University
Springfield, Illinois, 62702
University of South Florida- Research Foundation
Tampa, Florida, 33606
BRANY - Montefiore Medical Center
The Bronx, New York, 10467
University of Toledo
Toledo, Ohio, 43615
The Wisconsin Heart Hospital
Wauwatosa, Wisconsin, 53226
Clinical Research of Winston-Salem, Inc.
Winston-Salem, North Carolina, 27103
About this study
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
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).
Read the 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.
- Conditions
- End Stage Renal Failure on Dialysis, Hyperplasia
- Being tested
- Graft, Vascular Wrap, Lifespan® ePTFE Vascular Graft Only
- Keywords
- dialysis, hemodialysis, neointimal hyperplasia
- Medical subject headings
- Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graft, Vascular WrapDevice
Also called Vascular Wrap
Lifespan® ePTFE Vascular Graft and Vascular Wrap Paclitaxel-Eluting Mesh (0.9 µg/mm2 paclitaxel)
Lifespan® ePTFE Vascular Graft OnlyDevice
Vascular Graft only
| Study group | Role | What they receive |
|---|---|---|
| Graft, Vascular Wrap | Active comparator | Lifespan® ePTFE Vascular Graft and Vascular Wrap Paclitaxel-Eluting Mesh (0.9 µg/mm2 paclitaxel) Receives: Device: Graft, Vascular Wrap |
| Graft | Placebo comparator | Lifespan® ePTFE Vascular Graft Only Receives: Device: Lifespan® ePTFE Vascular Graft Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nature and incidence of Adverse Events between treatment groups clinical difference in product-related adverse events
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startMar 2008
- Primary completionMar 2010
- Study completionOct 2010
Why it stopped: Imbalance in the # graft infections between the tx's (graft vs. graft + wrap)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Failure on DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angiotech Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rui Avelar, M.D., Study chair, Angiotech Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033357
- Sponsor's protocol ID
- 014-VWAV07
- Status last verified
- Feb 2013
- First submitted
- 15 Dec 2009
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01033357
- Acronym / sponsor ID
- 014-VWAV07
- Conditions
- End Stage Renal Failure on Dialysis, Hyperplasia
- Keywords
- dialysis, hemodialysis, neointimal hyperplasia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Imbalance in the # graft infections between the tx's (graft vs. graft + wrap)
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Angiotech PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 16 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Graft, Vascular Wrap | Active comparator | Device: Graft, Vascular WrapLifespan® ePTFE Vascular Graft and Vascular Wrap Paclitaxel-Eluting Mesh (0.9 µg/mm2 paclitaxel) |
| Graft | Placebo comparator | Device: Lifespan® ePTFE Vascular Graft OnlyLifespan® ePTFE Vascular Graft Only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Subjects who withdrew or were withdrawn from study 012-VWAV06.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graft, Vascular WrapAlso: Vascular WrapLifespan® ePTFE Vascular Graft and Vascular Wrap Paclitaxel-Eluting Mesh (0.9 µg/mm2 paclitaxel) | Device | Graft, Vascular Wrap |
| Lifespan® ePTFE Vascular Graft OnlyVascular Graft only | Device | Graft |
Primary outcome
Nature and incidence of Adverse Events between treatment groups clinical difference in product-related adverse events
Time frame: 4 years
Results and safety
The study was stopped early (reason given: Imbalance in the # graft infections between the tx's (graft vs. graft + wrap)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rui Avelar, M.D. study chair
Angiotech Pharmaceuticals
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graft, Vascular Wrap and Lifespan® ePTFE Vascular Graft Only in people with End Stage Renal Failure on Dialysis and Hyperplasia, run by Angiotech Pharmaceuticals at 30 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Imbalance in the # graft infections between the tx's (graft vs. graft + wrap)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nature and incidence of Adverse Events between treatment groups clinical difference in product-related adverse events (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2013.