Clinical trial NCT02790606: Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft in AV Graft Patients (AVeVA)
Official title: Prospective, Multi-Center Clinical Study of the Bard® COVERA™ Arteriovenous (AV) Stent Graft in the Treatment of Stenosis at the Graft-Vein Anastomosis of AV Graft Circuits (AVeVA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stenosis
Restenosis
Keywords: ESRD
Stenosis
Restenosis
Hemodialysis
AV Graft
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2016-06-06
Enrollment: 110
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study will compare the use of the COVERA™ Vascular Covered Stent (following percutaneous transluminal angioplasty (PTA)) to safety and effectiveness performance goals (PGs) for the treatment of stenotic lesions in the upper extremity venous outflow of the arteriovenous (AV) access circuit of subjects dialyzing with an AV graft.

Eligibility criteria: 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 a synthetic AV access graft located in an arm that has been implanted for ≥ 30 days and must have undergone at least one successful dialysis session prior to the index procedure.

Angiographic Inclusion Criteria

* Subject must have angiographic evidence of a stenosis ≥ 50% (by visual estimation) located at the graft-vein anastomosis of the subject's synthetic AV access graft and present with clinical evidence of graft dysfunction at the synthetic AV graft-vein anastomosis.
* 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 vessel must be between 5.0 and 9.0mm.

Clinical Exclusion Criteria:

* The subject is dialyzing with an AV fistula.
* The hemodialysis access is located in the lower extremity.
* The subject has an infected AV access graft 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 or stent graft.
* 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 implantation of the study device.

Primary outcomes:
measure: Number of Participants With Freedom From AV Access Circuit Localized or Systemic Serious Adverse Events
timeFrame: 30 days post index procedure
measure: Effectiveness Endpoint: Number of Participants With Target Lesion Primary Patency
timeFrame: 6 months post index procedure
Secondary outcomes:
measure: Endpoint Without Hypothesis Testing: Number of Participants With Target Lesion Primary Patency (TLPP)
timeFrame: 1, 3, 6, 12, 18 and 24 months post index procedure
measure: Endpoint With Hypothesis Testing: Number of Participants With Access Circuit Primary Patency (ACPP)
timeFrame: 1, 3, 6, 12, 18 and 24 months post index procedure
measure: Endpoint Without Hypothesis Testing: Number of Participants With Device and Procedure Related AEs Involving the AV Access Circuit
timeFrame: 1, 3, 6, 12, 18 and 24 months post index procedure,
measure: Endpoint Without Hypothesis Testing: Total Number of Arteriovenous (AV) Access Circuit Reinterventions
timeFrame: 1, 3, 6, 12, 18 and 24 months post index procedure.
measure: Endpoint Without Hypothesis Testing: Total Number of Target Lesion Reinterventions
timeFrame: 1, 3, 6, 12, 18 and 24 months post index procedure
measure: Endpoint Without Hypothesis Testing: Index of Patency Function (IPF)
timeFrame: 1, 3, 6, 12, 18 and 24 months post index procedure
measure: Endpoint Without Hypothesis Testing: Index of Patency Function - Target Lesion (IPF-T)
timeFrame: 1, 3, 6, 12, 18 and 24 months post index procedure
measure: Endpoint Without Hypothesis Testing: Number of Participants With Post-intervention Secondary Patency
timeFrame: 1, 3, 6, 12, 18 and 24 months post index procedure
measure: Endpoint Without Hypothesis Testing: Number of Participants With Technical Success (for Stent Graft Placement)
timeFrame: At time of index procedure
measure: Endpoint Without Hypothesis Testing: Number of Participants With Procedure Success
timeFrame: At time of index procedure
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Kidney Disease and Hypertension Center
state: Arizona
city: Tempe
country: United States
facility: Southwest Vascular Center
state: Arizona
city: Tucson
country: United States
facility: Arizona Kidney Disease and Hypertension Center Medical Research Services, LLC
state: Arizona
city: Orange
country: United States
facility: St. Joseph Hospital
state: California
city: Sacramento
country: United States
facility: Capital Nephrology Access Center
state: California
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Ocala
country: United States
facility: Ocala Kidney Group
state: Florida
city: Chicago
country: United States
facility: Chicago Access Care
state: Illinois
city: West Springfield
country: United States
facility: Renal and Transplant Associates of New England, P.C.
state: Massachusetts
city: Westfield
country: United States
facility: The Cardiovascular Care Group
state: New Jersey
city: Charlotte
country: United States
facility: Surgical Specialists of Charlotte
state: North Carolina
city: Raleigh
country: United States
facility: NC Heart and Vascular Research
state: North Carolina
city: Raleigh
country: United States
facility: NC Nephrology
state: North Carolina
city: Providence
country: United States
facility: Providence Access Care
state: Rhode Island
city: Fort Worth
country: United States
facility: Tarrant Vascular Clinic
state: Texas
city: San Antonio
country: United States
facility: Clinical Advancement Center, PLLC
state: Texas
Study officials:
affiliation: The Palo Alto Medical Foundation
name: Bart Dolmatch, M.D.
role: PRINCIPAL_INVESTIGATOR
References: