Post Approval Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft
NCT ID: NCT04261686
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2020-07-03
2025-09-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Covera Vascular Covered Stent
This is a single-arm study. All subjects will receive the Covera Vascular Covered Stent
Interventions
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Covera Vascular Covered Stent
This is a single-arm study. All subjects will receive the Covera Vascular Covered Stent
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Subject must be willing to comply with the protocol requirements, including clinical and telephone follow-up.
4. 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.
5. 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.
6. The target lesion must be ≤ 9cm in length. Note: multiple stenoses may exist within the target lesion.
7. The reference vessel diameter of the adjacent non-stenotic vein must be between 5.0 and 9.0mm.
Exclusion Criteria
2. The target lesion has had a corresponding thrombosis treated within 7 days prior to the index procedure.
3. The hemodialysis access is located in the lower extremity.
4. The subject has an infected AV fistula or uncontrolled systemic infection.
5. The subject has a known uncontrolled blood coagulation/bleeding disorder.
6. The subject has a known allergy or hypersensitivity to contrast media which cannot be adequately pre-medicated.
7. The subject has a known hypersensitivity to nickel-titanium (Nitinol) or tantalum.
8. 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.
9. 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.
10. 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.
11. An aneurysm or pseudoaneurysm is present within the target lesion.
12. The location of the target lesion would require the COVERATM Vascular Covered Stent be deployed across the elbow joint.
13. The target lesion is located within a stent.
14. 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").
15. 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.
16. 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.
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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Arizona Kidney Disease and Hypertension Center Medical Research Services
Phoenix, Arizona, United States
Yale University
New Haven, Connecticut, United States
Chicago Access Care
Westmont, Illinois, United States
Kidney Care & Transplant Services of New England
West Springfield, Massachusetts, United States
Michigan Vascular Center
Flint, Michigan, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Minnesota Vascular and Surgery Center
New Brighton, Minnesota, United States
North Carolina Nephrology
Raleigh, North Carolina, United States
Providence Access Care
Providence, Rhode Island, United States
Dallas Renal Group
Dallas, Texas, United States
San Antonio Kidney and Disease Access Center
San Antonio, Texas, United States
Countries
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References
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Dolmatch B, Saber T, Underwood M; and AVeNEW PAS trial investigators. Six-Month Outcomes from the Prospective, Multi-Center, Non-Randomized Clinical Study of the COVERA() Arterio VeNous (AV) Stent Graft in the Treatment of Stenosis in the VEnous OutfloW of AV Fistula Access Circuits (AVeNEW PAS). Cardiovasc Intervent Radiol. 2025 Apr;48(4):460-471. doi: 10.1007/s00270-024-03930-7. Epub 2025 Jan 9.
Other Identifiers
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BDPI-19-001
Identifier Type: -
Identifier Source: org_study_id