Kidney DiseasesNCT00448708
Safety and Efficacy of Angiotech Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access
A study testing Vascular Wrap Paclitaxel-Eluting Mesh and Lifespan® ePTFE Vascular Graft in people with Kidney Diseases and ESRD, run by Angiotech Pharmaceuticals at 33 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Diseases, ESRD
- What is being tested?
- Vascular Wrap Paclitaxel-Eluting Mesh and Lifespan® ePTFE Vascular Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 33 sitesUnited States
- Study dates
- Mar 2007to Apr 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- be ≥ 18 years of age;
- if female of childbearing potential, provide evidence of a negative pregnancy test within 3 days prior to graft placement (Day -3 to Day 0);
- be a candidate for a new end-to-side arteriovenous anastomosis graft placed in the upper extremity;
- have an outflow vein of greater than or equal to 3 mm in diameter;
- be able to effectively communicate with study personnel;
- be considered by the physician to be available for subsequent visits;
Show all 11Show fewer
- be willing to comply with all aspects of the treatment and evaluation schedule over a 52 week duration;
- 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;
- sign and date an IRB-approved written informed consent prior to initiation of any study procedures, including screening procedures;
- 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
- have the Lifespan® ePTFE Vascular Graft successfully implanted.
Who cannot join
- 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;
- 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;
- a central venous stenosis on the ipsilateral side is documented;
- a hypercoagulable state is documented;
- life expectancy is less than one year;
- an organ transplant is expected within 6 months of test or control product (study products) placement;
Show all 13Show fewer
- hypersensitivity to any component of the study products or procedural materials or medications is known;
- concurrently involved in another investigational study;
- a study product being investigated by others has been received within 30 days prior to randomization in this trial;
- the study product being studied in this trial has previously been received;
- uncontrolled hypertension with systolic BP >200mmHg or diastolic BP >115mmHg is present at screening;
- currently receiving chemotherapy or radiation therapy; or
- placement of a new end-to-end arteriovenous anastomosis graft is required.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
Clinical Research Center
Birmingham, Alabama, 35213
University of Cincinnati Medical Center
Cincinnati, Ohio, 45206
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
The Wisconsin Heart Hospital
Milwaukee, Wisconsin, 53217
St. Luke's Roosevelt Hospital Center
New York, New York, 10025
Discovery Medical Research Group
Ocala, Florida, 34471
Baptist Cancer Institute
Pensacola, Florida, 32501
Renal Care Associates
Peoria, Illinois, 61603
Rex Hospital
Raleigh, North Carolina, 27606
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
Southeastern Urological Center, P.A
Tallahassee, Florida, 32308
University of South Florida- Research Foundation
Tampa, Florida, 33606
Biomedical Research Alliance of New York
The Bronx, New York, 10461
BRANY - Montefiore Medical Center
The Bronx, New York, 10467
University of Toledo
Toledo, Ohio, 43615
Clinical Research of Winston-Salem, Inc.
Winston-Salem, North Carolina, 27103
About this study
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
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
- Conditions
- Kidney Diseases, ESRD
- Being tested
- Vascular Wrap Paclitaxel-Eluting Mesh, Lifespan® ePTFE Vascular Graft
- Keywords
- Hemodialysis Access
- Medical subject headings
- Kidney Diseases, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular Wrap Paclitaxel-Eluting MeshDevice
Also called Vascular Wrap, paclitaxel mesh
0.9 µg/mm^2 paclitaxel
Lifespan® ePTFE Vascular GraftDevice
vascular graft
Lifespan® ePTFE Vascular GraftDevice
vascular graft
| Study group | Role | What they receive |
|---|---|---|
| Vascular Wrap and Graft | Experimental | 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. Receives: Device: Vascular Wrap Paclitaxel-Eluting Mesh; Device: Lifespan® ePTFE Vascular Graft |
| Lifespan® ePTFE Vascular Graft | No intervention | 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. Receives: Device: Lifespan® ePTFE Vascular Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-loss of Target Site Primary Patency
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.
Measured: 1 year
Secondary outcomes (1)
Adverse Events
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionApr 2009
- Study completionApr 2009
Why it stopped: Due to an imbalance in graft infections between groups.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney DiseasesStudies 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, MD, Study chair, Angiotech Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448708
- Sponsor's protocol ID
- 012-VWAV06
- Status last verified
- Oct 2011
- First submitted
- 15 Mar 2007
- Last updated
- 17 Nov 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00448708
- Acronym / sponsor ID
- 012-VWAV06
- Conditions
- Kidney Diseases, ESRD
- Keywords
- Hemodialysis Access
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to an imbalance in graft infections between groups.
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Angiotech PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 19 Mar 2007 (estimated)
- Results
- Posted 17 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vascular Wrap and Graft | Experimental | Device: Vascular Wrap Paclitaxel-Eluting Mesh, Device: Lifespan® ePTFE Vascular GraftLifespan® 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. |
| Lifespan® ePTFE Vascular Graft | No intervention | Device: Lifespan® ePTFE Vascular GraftLifespan® ePTFE Vascular Graft Only: The Lifespan® ePTFE Vascular Graft is implanted as an arteriovenous graft in an upper extremity to provide a hemodialysis access. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- be ≥ 18 years of age;
- if female of childbearing potential, provide evidence of a negative pregnancy test within 3 days prior to graft placement (Day -3 to Day 0);
- be a candidate for a new end-to-side arteriovenous anastomosis graft placed in the upper extremity;
- have an outflow vein of greater than or equal to 3 mm in diameter;
- be able to effectively communicate with study personnel;
Key exclusion criteria (13 listed)
- 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;
- 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;
- a central venous stenosis on the ipsilateral side is documented;
- a hypercoagulable state is documented;
- life expectancy is less than one year;
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 |
|---|---|---|
| Vascular Wrap Paclitaxel-Eluting MeshAlso: Vascular Wrap, paclitaxel mesh0.9 µg/mm^2 paclitaxel | Device | Vascular Wrap and Graft |
| Lifespan® ePTFE Vascular Graftvascular graft | Device | Vascular Wrap and Graft |
| Lifespan® ePTFE Vascular Graftvascular graft | Device | Lifespan® ePTFE Vascular Graft |
Primary outcome
Time-to-loss of Target Site Primary Patency
Time frame: 1 year
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.
1 secondary outcome
Adverse Events
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Kidney Diseases
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
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, MD study chair
Angiotech Pharmaceuticals
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vascular Wrap Paclitaxel-Eluting Mesh and Lifespan® ePTFE Vascular Graft in people with Kidney Diseases and ESRD, run by Angiotech Pharmaceuticals at 33 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 11 inclusion and 13 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 17 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 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. 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?
Yes. Results are posted in the registry (first posted 17 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time-to-loss of Target Site Primary Patency (time frame: 1 year). 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 17 Nov 2011.