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

NCT ID: NCT02790606

Last Updated: 2020-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2019-03-16

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.

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.

Conditions

Stenosis; Restenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Covera(TM) Vascular Covered Stent

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

Group Type: EXPERIMENTAL

Covera(TM) Vascular Covered Stent

Intervention Type: DEVICE

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

Interventions

Covera(TM) Vascular Covered Stent

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• 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.

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.

• 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bart Dolmatch, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Palo Alto Medical Foundation

Locations

Arizona Kidney Disease and Hypertension Center

Phoenix, Arizona, United States

Southwest Vascular Center

Tempe, Arizona, United States

Arizona Kidney Disease and Hypertension Center Medical Research Services, LLC

Tucson, Arizona, United States

St. Joseph Hospital

Orange, California, United States

Capital Nephrology Access Center

Sacramento, California, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Ocala Kidney Group

Ocala, Florida, United States

Chicago Access Care

Chicago, Illinois, United States

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

West Springfield, Massachusetts, United States

The Cardiovascular Care Group

Westfield, New Jersey, United States

Surgical Specialists of Charlotte

Charlotte, North Carolina, United States

NC Heart and Vascular Research

Raleigh, North Carolina, United States

NC Nephrology

Raleigh, North Carolina, United States

Providence Access Care

Providence, Rhode Island, United States

Tarrant Vascular Clinic

Fort Worth, Texas, United States

Clinical Advancement Center, PLLC

San Antonio, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BPV-15-001

Identifier Type: -

Identifier Source: org_study_id