Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft
NCT ID: NCT02649946
Last Updated: 2021-12-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
280 participants
INTERVENTIONAL
2016-06-30
2021-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Covera Vascular Covered Stent following PTA
Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)
Covera Vascular Covered Stent following PTA
Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.
PTA only using uncoated PTA Balloon
Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.
Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon
Treatment of stenoses with PTA only
Interventions
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Covera Vascular Covered Stent following PTA
Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.
Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon
Treatment of stenoses with PTA only
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject must be either a male or non-pregnant female ≥ 21 years of age with an expected lifespan sufficient to allow for completion of all study procedures.
* Subject must be willing to comply with the protocol requirements, including the clinical and telephone follow-up.
* Subject must have an upper extremity arteriovenous (AV) fistula that has undergone at least one successful dialysis session with two-needle cannulation, prior to the index procedure.
* Subject must have angiographic evidence of a stenosis ≥ 50% (by visual estimation) located in the venous outflow of the AV access circuit and present with clinical or hemodynamic evidence of AV fistula dysfunction.
* The target lesion must be ≤ 9cm in length. Note: multiple stenoses may exist within the target lesion.
* The reference vessel diameter of the adjacent non-stenotic vein must be between 5.0 and 9.0mm.
Exclusion Criteria
* The target lesion has had a corresponding thrombosis treated within 7 days prior to the index procedure.
* The hemodialysis access is located in the lower extremity.
* The subject has an infected AV fistula or uncontrolled systemic infection.
* The subject has a known uncontrolled blood coagulation/bleeding disorder.
* The subject has a known allergy or hypersensitivity to contrast media which cannot be adequately pre-medicated.
* The subject has a known hypersensitivity to nickel-titanium (Nitinol) or tantalum.
* The subject has another medical condition, which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up.
* The subject is currently participating in an investigational drug or another device study that has not completed the study treatment or that clinically interferes with the study endpoints. Note: Studies requiring extended follow-up visits for products that were investigational, but have since become commercially available, are not considered investigational studies.
* Additional stenotic lesions (≥ 50%) in the venous outflow that are \> 3cm from the edge of the target lesion and are not successfully treated (defined as \< 30% residual stenosis) prior to treating the target lesion.
* An aneurysm or pseudoaneurysm is present within the target lesion.
* The location of the target lesion would require the COVERA™ Vascular Covered Stent be deployed across the elbow joint.
* The target lesion is located within a stent.
* The location of the target lesion would require that the COVERA™ Vascular Covered Stent be deployed at or across the segment of fistula utilized for dialysis needle puncture (i.e., "cannulation zone").
* The location of the target lesion would require that the COVERA™ Vascular Covered Stent be placed in the central veins (subclavian, brachiocephalic, superior vena cava (SVC)) or under the clavicle at the thoracic outlet.
* There is incomplete expansion of an appropriately sized angioplasty balloon to its expected profile, in the operator's judgment, during primary angioplasty at the target lesion prior to randomization.
21 Years
ALL
No
Sponsors
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C. R. Bard
INDUSTRY
Responsible Party
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Principal Investigators
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Bart Dolmatch, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Palo Alto Medical Foundation
Locations
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Southwest Vascular Center
Tempe, Arizona, United States
Alliance Research Centers
Laguna Hills, California, United States
Radiology Imaging Associates
Englewood, Colorado, United States
Yale University & Yale New Haven Hospital
New Haven, Connecticut, United States
Nephrology Associates, P.A.
Newark, Delaware, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, United States
Ocala Kidney Group
Ocala, Florida, United States
Chicago Access Care
Chicago, Illinois, United States
Indiana University Hospital
Indianapolis, Indiana, United States
Renal and Transplant Associates of New England, P.C.
West Springfield, Massachusetts, United States
NC Heart and Vascular Research
Raleigh, North Carolina, United States
NC Nephrology
Raleigh, North Carolina, United States
Providence Access Care
Providence, Rhode Island, United States
Tarrant Vascular Clinic
Fort Worth, Texas, United States
Clinical Advancement Center, PLLC
San Antonio, Texas, United States
Flinders Medical Centre
Bedford Park, South Australia, Australia
Royal Adelaide Hospital
Kensington Gardens, South Australia, Australia
LKH-Univ. Klinikum Graz
Graz, , Austria
University Hospital Leuven
Leuven, Vlaams-Brabant, Belgium
Universitätsklinikum Würzburg
Würzburg, , Germany
Maastricht Universitair Medish Centrum
Maastricht, , Netherlands
Middlemore Hospital
Auckland, , New Zealand
Universitaets Spital Zurich
Zurich, , Switzerland
Countries
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References
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Dolmatch B, Cabrera T, Pergola P, Balamuthusamy S, Makris A, Cooper R, Moore E, Licht J, Macaulay E, Maleux G, Pfammatter T, Settlage R, Cristea E, Lansky A; AVeNEW Trial Investigators. Prospective, randomized, multicenter clinical study comparing a self-expanding covered stent to percutaneous transluminal angioplasty for treatment of upper extremity hemodialysis arteriovenous fistula stenosis. Kidney Int. 2023 Jul;104(1):189-200. doi: 10.1016/j.kint.2023.03.015. Epub 2023 Mar 27.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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BPV-14-005
Identifier Type: -
Identifier Source: org_study_id