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

NCT02649946 | Completed Results DMC

• 1 other identifier: BPV-14-005
• Study Type: interventional
• Target: 280
• Locations: 7 countries
• Sites: 22

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 Fistula; Arteriovenous (AV)

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  30 days post index procedure

Secondary Outcomes (12)

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

  12 months post-index procedure

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

  6 months post index procedure

• Number of Participants With Target Lesion Primary Patency (TLPP)

  1, 3, 18 and 24 months post index procedure

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

  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

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

Study Arms (2)

Covera Vascular Covered Stent following PTA

EXPERIMENTAL

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

Device: Covera Vascular Covered Stent following PTA

PTA only using uncoated PTA Balloon

ACTIVE COMPARATOR

Percutaneous Transluminal Angioplasty (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.

Procedure: Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon

Interventions

Covera Vascular Covered Stent following PTA DEVICE

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

Covera Vascular Covered Stent following PTA

Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon PROCEDURE

Treatment of stenoses with PTA only

Also known as: Standard Balloon Angioplasty (POBA)

PTA only using uncoated PTA Balloon

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 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (24)

Southwest Vascular Center

Tempe, Arizona, 85281, United States

Location

Alliance Research Centers

Laguna Hills, California, 92653, United States

Location

Radiology Imaging Associates

Englewood, Colorado, 80112, United States

Location

Yale University & Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

Nephrology Associates, P.A.

Newark, Delaware, 19713, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32207, United States

Location

First Coast Cardiovascular Institute

Jacksonville, Florida, 32216, United States

Location

Ocala Kidney Group

Ocala, Florida, 34471, United States

Location

Chicago Access Care

Chicago, Illinois, 60521, United States

Location

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

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

West Springfield, Massachusetts, 01089, 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

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

Royal Adelaide Hospital

Kensington Gardens, South Australia, 5068, Australia

Location

LKH-Univ. Klinikum Graz

Graz, 8036, Austria

Location

University Hospital Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

Maastricht Universitair Medish Centrum

Maastricht, 6202, Netherlands

Location

Middlemore Hospital

Auckland, 2025, New Zealand

Location

Universitaets Spital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

• Dolmatch B, Cabrera T, Pergola P, Balamuthusamy S, Makris A, Cooper R, Moore E, Licht J, Macaulay E, Maleux G, Pfammatter T, Settlage R, Cristea E, Lansky A; AVeNEW Trial Investigators. Prospective, randomized, multicenter clinical study comparing a self-expanding covered stent to percutaneous transluminal angioplasty for treatment of upper extremity hemodialysis arteriovenous fistula stenosis. Kidney Int. 2023 Jul;104(1):189-200. doi: 10.1016/j.kint.2023.03.015. Epub 2023 Mar 27.

  PMID: 36990214 DERIVED

MeSH Terms

Conditions

Constriction, Pathologic; Kidney Failure, Chronic; Arteriovenous Fistula

Interventions

Angioplasty

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; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Results Point of Contact

• Title: Heather Lam, Associate Project Manager, Clinical Affairs
• Organization: BD/Bard

heather.lam@bd.com

(763) 390-8616

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: January 8, 2016
• Study Start: June 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: February 1, 2021
• Last Updated: December 21, 2021
• Results First Posted: May 13, 2019

Record last verified: 2021-12

Locations

AU (1); BE (1); DE (1); CH (1); NZ (1); NL (1); US (16)