Post Approval Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft (NCT04261686) | Clinical Trial Compass
CompletedNot Applicable
Post Approval Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft
United States100 participantsStarted 2020-07-03
Plain-language summary
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.
Who can participate
Age range21 Years
SexALL
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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
✕. 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.
What they're measuring
1
Safety through 30 days
Timeframe: Through 30 days following index procedure
2
Target Lesion Primary Patency (TLPP)
Timeframe: 1, 3, 6, 12, 18, 24, and 36 months following post-index procedure
3
Access Circuit Primary Patency (ACPP)
Timeframe: 1, 3, 6, 12, 18, 24, and 36 months post index procedure
4
Rate of Device and Procedure Related Adverse Events involving the access circuit
Timeframe: 1, 3, 6, 12, 18, 24, and 36 months post index procedure.
5
Total Number of Arteriovenous (AV) Access Circuit Reinterventions
Timeframe: 1, 3, 6, 12, 18, 24, and 36 months post index procedure
6
Total Number of Target Lesion Reinterventions
Timeframe: 1, 3, 6, 12, 18, 24, and 36 months post index procedure
7
Index of Patency Function (IPF)
Timeframe: 1, 3, 6, 12, 18, 24, and 36 months post index procedure
✕. 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.
Timeframe: 1, 3, 6, 12, 18, 24, and 36 months post index procedure
9
Post-Intervention Secondary Patency
Timeframe: 1, 3, 6, 12, 18, 24, and 36 months post index procedure