- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04261686
Post Approval Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft
April 15, 2024 updated by: C. R. Bard
A Prospective, Multi-Center, Non-Randomized Clinical Study of the BARD® COVERA Arteriovenous (AV) Stent Graft in the Treatment of Stenosis in the Venous Outflow of AV Fistula Access Circuits (AVeNEW) Post Approval Study
The objective of this study is to collect post-market, real-world safety and effectiveness data of the COVERA Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the arteriovenous (AV) access circuit.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Prospective, multi-center, non-randomized clinical study designed to assess the long-term safety and effectiveness of the COVERA Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the AV access circuit of hemodialysis subjects dialyzing with an arteriovenous (AV) fistula.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85012
- Arizona Kidney Disease and Hypertension Center Medical Research Services
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Connecticut
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New Haven, Connecticut, United States, 06511
- Yale University
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Illinois
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Westmont, Illinois, United States, 60559
- Chicago Access Care
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Massachusetts
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West Springfield, Massachusetts, United States, 01089
- Kidney Care & Transplant Services of New England
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Michigan
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Flint, Michigan, United States, 48507
- Michigan Vascular Center
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Medical Center
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New Brighton, Minnesota, United States, 55112
- Minnesota Vascular and Surgery Center
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North Carolina
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Raleigh, North Carolina, United States, 27610
- North Carolina Nephrology
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Rhode Island
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Providence, Rhode Island, United States, 02906
- Providence Access Care
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Texas
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Dallas, Texas, United States, 75208
- Dallas Renal Group
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San Antonio, Texas, United States, 78216
- San Antonio Kidney and Disease Access Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Clinical Inclusion Criteria
- Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures.
- 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 clinical and telephone follow-up.
- Subject must have an upper extremity 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:
Clinical Exclusion Criteria
- The subject is dialyzing with an AV graft.
- 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 COVERATM 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: COVERA Vascular Covered Stent
COVERA Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the arteriovenous (AV) access circuit of hemodialysis subjects dialyzing with an AV fistula.
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This is a single-arm study.
All subjects will receive the Covera Vascular Covered Stent
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety through 30 days
Time Frame: Through 30 days following index procedure
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Freedom from any adverse event(s), localized or systemic, that reasonably suggest the involvement of the AV access circuit that require or result in any of the following alone or in combination: additional interventions, in-patient hospitalization or prolongation of an existing hospitalization; or death.
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Through 30 days following index procedure
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Target Lesion Primary Patency (TLPP)
Time Frame: 1, 3, 6, 12, 18, 24, and 36 months following post-index procedure
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The interval following the index intervention until the next clinically driven reintervention at or adjacent to the original treatment site, or until the extremity is abandoned for permanent access.
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1, 3, 6, 12, 18, 24, and 36 months following post-index procedure
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Access Circuit Primary Patency (ACPP)
Time Frame: 1, 3, 6, 12, 18, 24, and 36 months post index procedure
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The interval following the index intervention until the next access thrombosis or repeated intervention.
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1, 3, 6, 12, 18, 24, and 36 months post index procedure
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Rate of Device and Procedure Related Adverse Events involving the access circuit
Time Frame: 1, 3, 6, 12, 18, 24, and 36 months post index procedure.
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Rate of device and procedure related adverse events (AEs) involving the access circuit.
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1, 3, 6, 12, 18, 24, and 36 months post index procedure.
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Total Number of Arteriovenous (AV) Access Circuit Reinterventions
Time Frame: 1, 3, 6, 12, 18, 24, and 36 months post index procedure
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Number of reinterventions to the arteriovenous (AV) access circuit until access abandonment or through study completion.
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1, 3, 6, 12, 18, 24, and 36 months post index procedure
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Total Number of Target Lesion Reinterventions
Time Frame: 1, 3, 6, 12, 18, 24, and 36 months post index procedure
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Number of reinterventions to maintain target lesion patency
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1, 3, 6, 12, 18, 24, and 36 months post index procedure
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Index of Patency Function (IPF)
Time Frame: 1, 3, 6, 12, 18, 24, and 36 months post index procedure
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Time from the index study procedure to study completion or access abandonment divided by the number of visits for a reintervention performed on the arteriovenous (AV) access circuit in order to maintain vascular access for hemodialysis.
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1, 3, 6, 12, 18, 24, and 36 months post index procedure
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Index of Patency Function for Target Lesion
Time Frame: 1, 3, 6, 12, 18, 24, and 36 months post index procedure
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Time from the index study procedure to study completion or complete access abandonment divided by the number of visits for a reintervention performed at the target lesion in order to maintain vascular access for hemodialysis.
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1, 3, 6, 12, 18, 24, and 36 months post index procedure
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Post-Intervention Secondary Patency
Time Frame: 1, 3, 6, 12, 18, 24, and 36 months post index procedure
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The interval after the index intervention until the access is abandoned.
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1, 3, 6, 12, 18, 24, and 36 months post index procedure
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Acute Technical Success for Stent Graft Placement
Time Frame: At time of index procedure
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Defined as the successful deployment, based on the operator's opinion, of the implant to the intended location assessed at the time of the index procedure.
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At time of index procedure
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Acute Procedural Success
Time Frame: At time of index procedure
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Defined as anatomic success and resolution of the pre-procedural clinical indicator(s) (clinical success) of a hemodynamically significant stenosis
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At time of index procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bart Dolmatch, M.D., The Palo Alto Medical Foundation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 3, 2020
Primary Completion (Estimated)
November 18, 2025
Study Completion (Estimated)
November 18, 2025
Study Registration Dates
First Submitted
February 6, 2020
First Submitted That Met QC Criteria
February 6, 2020
First Posted (Actual)
February 10, 2020
Study Record Updates
Last Update Posted (Actual)
April 16, 2024
Last Update Submitted That Met QC Criteria
April 15, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BDPI-19-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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