Clinical trial NCT02649946: Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft
Official title: A Prospective, Multi-Center, Randomized, Concurrently-Controlled Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft in the Treatment of Stenosis in the Venous Outflow of AV Fistula Access Circuits (AVeNEW)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stenosis
Restenosis
Keywords: ESRD
Stenosis
Restenosis
Hemodialysis
AV Fistula
Arteriovenous (AV)
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2016-01-08
Enrollment: 280
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 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.

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 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.

Primary outcomes:
measure: Effectiveness Endpoint: Number of Participants With Target Lesion Primary Patency (TLPP)
timeFrame: 6 months post index procedure
measure: Number of Participants With Freedom From AV Access Circuit Localized or Systemic Serious Adverse Events
timeFrame: 30 days post index procedure
Secondary outcomes:
measure: Number of Patients With Target Lesion Primary Patency (TLPP) at 12 Months Post Index Procedure
timeFrame: 12 months post-index procedure
measure: Number of Participants With Access Circuit Primary Patency (ACPP).
timeFrame: 6 months post index procedure
measure: Number of Participants With Target Lesion Primary Patency (TLPP)
timeFrame: 1, 3, 18 and 24 months post index procedure
measure: Number of Participants With Access Circuit Primary Patency (ACPP)
timeFrame: 1, 3, 12, 18, and 24 months post index procedure
measure: Number of Participants Free From Device and Procedure Related AEs Involving the AV Access Circuit
timeFrame: Evaluation through 1, 3, 6, 12, 18, and 24 months post-index procedure
measure: Total Number of Arteriovenous (AV) Access Circuit Reinterventions
timeFrame: 1, 3, 6, 12, 18 and 24 months post index procedure
measure: Total Number of Target Lesion Reinterventions
timeFrame: 1, 3, 6, 12, 18 and 24 months post index procedure
measure: Index of Patency Function (IPF)
timeFrame: 1, 3, 6, 12, 18 and 24 months post index procedure
measure: Index of Patency Function - Target Lesion (IPF-T)
timeFrame: 1, 3, 6, 12, 18 and 24 months post index procedure
measure: Number of Participants With Post-intervention Secondary Patency
timeFrame: 1, 3, 6, 12, 18 and 24 months post index procedure
measure: Number of Participants With Technical Success
timeFrame: On Day of Index Procedure
measure: Number of Participants With Procedure Success
timeFrame: On Day of Index Procedure
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Southwest Vascular Center
state: Arizona
city: Laguna Hills
country: United States
facility: Alliance Research Centers
state: California
city: Englewood
country: United States
facility: Radiology Imaging Associates
state: Colorado
city: New Haven
country: United States
facility: Yale University & Yale New Haven Hospital
state: Connecticut
city: Newark
country: United States
facility: Nephrology Associates, P.A.
state: Delaware
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute
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: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
city: West Springfield
country: United States
facility: Renal and Transplant Associates of New England, P.C.
state: Massachusetts
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
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Kensington Gardens
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Graz
country: Austria
facility: LKH-Univ. Klinikum Graz
city: Leuven
country: Belgium
facility: University Hospital Leuven
state: Vlaams-Brabant
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medish Centrum
city: Auckland
country: New Zealand
facility: Middlemore Hospital
city: Zurich
country: Switzerland
facility: Universitaets Spital Zurich
Study officials:
affiliation: The Palo Alto Medical Foundation
name: Bart Dolmatch, M.D.
role: PRINCIPAL_INVESTIGATOR
References: