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

NCT02790606 | Completed Results DMC FDA Device

• 1 other identifier: BPV-15-001
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 16

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.

Conditions

Stenosis; Restenosis

Keywords

ESRD; Stenosis; Restenosis; Hemodialysis; AV Graft

Outcome Measures

Primary Outcomes (2)

• 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.

  30 days post index procedure

• Effectiveness Endpoint: Number of Participants With Target Lesion Primary Patency

  Target Lesion Primary Patency (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 access graft due to inability to treat the original treatment area. The primary effectiveness endpoint is evaluated against a performance goal (PG) of 40%.

  6 months post index procedure

Secondary Outcomes (10)

• Endpoint Without Hypothesis Testing: Number of Participants With Target Lesion Primary Patency (TLPP)

  1, 3, 6, 12, 18 and 24 months post index procedure

• Endpoint With Hypothesis Testing: Number of Participants With Access Circuit Primary Patency (ACPP)

  1, 3, 6, 12, 18 and 24 months post index procedure

• Endpoint Without Hypothesis Testing: Number of Participants With Device and Procedure Related AEs Involving the AV Access Circuit

  1, 3, 6, 12, 18 and 24 months post index procedure,

• Endpoint Without Hypothesis Testing: Total Number of Arteriovenous (AV) Access Circuit Reinterventions

  1, 3, 6, 12, 18 and 24 months post index procedure.

• Endpoint Without Hypothesis Testing: Total Number of Target Lesion Reinterventions

  1, 3, 6, 12, 18 and 24 months post index procedure

Study Arms (1)

Covera(TM) Vascular Covered Stent

EXPERIMENTAL

Placement of the Covera Vascular Covered Stent following percutaneous transluminal angioplasty (PTA)

Device: Covera(TM) Vascular Covered Stent

Interventions

Covera(TM) Vascular Covered Stent DEVICE

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

Covera(TM) Vascular Covered Stent

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (16)

Arizona Kidney Disease and Hypertension Center

Phoenix, Arizona, 85012, United States

Location

Southwest Vascular Center

Tempe, Arizona, 85281, United States

Location

Arizona Kidney Disease and Hypertension Center Medical Research Services, LLC

Tucson, Arizona, 85712, United States

Location

St. Joseph Hospital

Orange, California, 92868, United States

Location

Capital Nephrology Access Center

Sacramento, California, 95815, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32207, United States

Location

Ocala Kidney Group

Ocala, Florida, 34471, United States

Location

Chicago Access Care

Chicago, Illinois, 60521, United States

Location

Renal and Transplant Associates of New England, P.C.

West Springfield, Massachusetts, 01089, United States

Location

The Cardiovascular Care Group

Westfield, New Jersey, 07090, United States

Location

Surgical Specialists of Charlotte

Charlotte, North Carolina, 28207, United States

Location

NC Heart and Vascular Research

Raleigh, North Carolina, 27607, United States

Location

NC Nephrology

Raleigh, North Carolina, 27610, United States

Location

Providence Access Care

Providence, Rhode Island, 02906, United States

Location

Tarrant Vascular Clinic

Fort Worth, Texas, 76104, United States

Location

Clinical Advancement Center, PLLC

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Conditions

Constriction, Pathologic; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Results Point of Contact

• Title: Talar Saber, Clinical Project Manager
• Organization: C.R. Bard

talar.saber@crbard.com

480-379-2839

Study Officials

• Bart Dolmatch, M.D.

  The Palo Alto Medical Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: June 6, 2016
• Study Start: July 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: March 16, 2019
• Last Updated: April 14, 2020
• Results First Posted: February 26, 2019

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)