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

Kidney Diseases Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00448708
• Other study ID #: 012-VWAV06
• Status: Terminated
• Phase: N/A
• First received: March 15, 2007
• Last updated: October 13, 2011
• Start date: March 2007
• Est. completion date: April 2009

Study information

• Verified date: October 2011
• Source: Angiotech Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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. During the study period subjects must also maintain an appropriate hemodialysis schedule.

IDE Number: G060250

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 222
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• ESRD
• Kidney Diseases

Intervention

Device:
• Vascular Wrap Paclitaxel-Eluting Mesh
0.9 µg/mm^2 paclitaxel
• Lifespan® ePTFE Vascular Graft
vascular graft
• Lifespan® ePTFE Vascular Graft
vascular graft

Locations

Country	Name	City	State
United States	Clinical Research Center	Birmingham	Alabama
United States	Biomedical Research Alliance of New York	Bronx	New York
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	The Wisconsin Heart Hospital	Milwaukee	Wisconsin
United States	St. Luke's Roosevelt Hospital Center	New York	New York
United States	Discovery Medical Research Group	Ocala	Florida
United States	Baptist Cancer Institute	Pensacola	Florida
United States	Renal Care Associates	Peoria	Illinois
United States	Rex Hospital	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	Southeastern Urological Center, P.A	Tallahassee	Florida
United States	University of South Florida- Research Foundation	Tampa	Florida
United States	University of Toledo	Toledo	Ohio
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	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.	1 year	No
Secondary	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.	1 year	Yes