Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft (NCT02649946) | Clinical Trial Compass
CompletedNot Applicable
Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft
United States280 participantsStarted 2016-06
Plain-language summary
The objective of this study is to assess the safety and effectiveness 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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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 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.
Angiographic Inclusion Criteria:
* 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.
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 ha…
What they're measuring
1
Effectiveness Endpoint: Number of Participants With Target Lesion Primary Patency (TLPP)
Timeframe: 6 months post index procedure
2
Number of Participants With Freedom From AV Access Circuit Localized or Systemic Serious Adverse Events