Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft

C. R. Bard280 enrolled

Overview

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.

This study will compare the use of the COVERA™ Vascular Covered Stent (following percutaneous transluminal angioplasty (PTA)) to PTA alone for the treatment of stenotic lesions in the upper extremity venous outflow of the arteriovenous (AV) access circuit of subjects dialyzing with an AV fistula.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

280

Conditions

Stenosis Restenosis

Interventions

Covera Vascular Covered Stent following PTADEVICE

Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.

Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA BalloonPROCEDURE

Treatment of stenoses with PTA only

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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 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. Angiographic Exclusion Criteria: * 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.

Locations (24)

Southwest Vascular Center

Tempe, Arizona, United States

Outcomes

Primary Outcomes

Effectiveness Endpoint: Number of Participants With Target Lesion Primary Patency (TLPP)

TLPP is defined as 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. Primary patency ends when any of the following occurs: a) clinically driven reintervention in the treatment area; b) thrombotic occlusion within the treatment area; c) surgical intervention that excludes the original treatment area from the AV circuit, and/or d) abandonment of the AV fistula due to inability to treat the original treatment area. COVERA Vascular Covered Stent (following PTA) is evaluated against subjects treated PTA alone.

Time frame: 6 months post index procedure

Number of Participants With Freedom From AV Access Circuit Localized or Systemic Serious Adverse Events

Safety is defined as freedom from any adverse event(s) (AEs), localized or systemic, that reasonably suggests the involvement of the AV access circuit (not including stenosis or thrombosis) that require or result in any of the following alone or in combination: additional interventions (including surgery); in-patient hospitalization or prolongation of an existing hospitalization; or death.

Time frame: 30 days post index procedure

Secondary Outcomes

Number of Patients With Target Lesion Primary Patency (TLPP) at 12 Months Post Index Procedure

TLPP is defined as the interval following the index intervention until the next clinically driven reintervention at the original treatment site or until the extremity is abandoned for permanent access. Primary patency ends when any of the following occurs: a) clinically driven reintervention in the treatment area; b) thrombotic occlusion within the treatment area; c) surgical intervention that excludes the original treatment area from the AV circuit, and/or d) abandonment of the AV fistula due to inability to treat the original treatment area.

Time frame: 12 months post-index procedure

Number of Participants With Access Circuit Primary Patency (ACPP).

Data from ClinicalTrials.gov

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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

...and 14 more locations

ACPP is defined as the interval following the index intervention until the next access thrombosis or repeated intervention. ACPP ends with a reintervention anywhere within the access circuit. Vessel rupture caused by PTA is not an ACPP failure unless achieving hemostasis also causes thrombosis. Testing of this secondary endpoint is performed in a hierarchical fashion. Thus, In order to perform hypothesis test of ACPP at 6-month, TLPP at 12-months must be successful.

Time frame: 6 months post index procedure

Number of Participants With Target Lesion Primary Patency (TLPP)

Defined as the interval following the index intervention until the next clinically driven reintervention at the original treatment site or until the extremity is abandoned for permanent access. mITT subjects results are presented. N= number of subjects in the mITT Population with evaluable data. Evaluation through 1, 3, 18 and 24 months post index procedure.

Time frame: 1, 3, 18 and 24 months post index procedure

Number of Participants With Access Circuit Primary Patency (ACPP)

ACPP is defined as the interval following the index intervention until the next access thrombosis or repeated intervention. N = number of subjects in the mITT Population with evaluable data.

Time frame: 1, 3, 12, 18, and 24 months post index procedure

Number of Participants Free From Device and Procedure Related AEs Involving the AV Access Circuit

Number of Participants Free from Device and Procedure Related AEs Involving the AV Access Circuit (ITT population). Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days, 90 days and 6 months follow-up or did not meet endpoint inclusion criteria. The relationships with device/procedure of the events are based on CEC adjudications.

Time frame: Evaluation through 1, 3, 6, 12, 18, and 24 months post-index procedure

Total Number of Arteriovenous (AV) Access Circuit Reinterventions

Defined as the number of reinterventions to the AV access circuit until access abandonment or through study completion. Whereas the outcome measure time frames for the overall study are 1, 3, 6, 12,18 and 24 months, the interim report only provides the 1, 3, and 6 months results. The 12,18 and 24 months results will be provided in the final reporting for the study. MITT results are presented for this analysis.