BEACH Trial: Bovine Early Access, Compatibility and Hemostasis Trial

NCT04146012 | Terminated Phase 3 Results DMC FDA Device

• 1 other identifier: ARTCT.BEACH.001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

Brief Summary

Bovine Early Access, Compatibility, and Hemostasis (BEACH) Trial Study is to evaluate the Safety and Effectiveness of Early Access in Patients Who Require an Arteriovenous Conduit for Hemodialysis using the Artegraft® Collagen Vascular Graft™. The objective of the BEACH Trial is to demonstrate that early access of Artegraft is associated with acceptable rates of successful early access, and acceptable rates of a composite of adverse events, to support a modification of existing device labeling stating that Artegraft is capable of cannulation within 72 hours post implantation.

Conditions

Renal Insufficiency,Chronic

Outcome Measures

Primary Outcomes (2)

• Number of Participants That Were Successfully Cannulated.

  Early access success, defined by three cannulations, the first one started within 72 hours after implantation, all with minimum dialysis flow rates of 250 ml/min pump flow rate, with a minimum 17-gauge needle.

  less than 72 hours

• Patients That Experienced Major Adverse Events

  A composite of major adverse clinical events (MACE) including perigraft infection, hemorrhage / hematoma, thrombosis, and pseudoaneurysm within 30 days after first cannulation \[Day 0\] in the early-access and late-access groups.

  Less than 6 month

Secondary Outcomes (3)

• Grafts That Were Patent After 30 Days

  Less than 6 months

• Patients That Experience Major Adverse Events

  Less than 6 months

• Removal of Catheter After Implantation (For Information Only)

  Less than 6 months

Study Arms (2)

Early Access

ACTIVE COMPARATOR

Artegraft® Collagen Vascular Graft™ (Artegraft) will be accessed in less than 72 hours after implantation.

Device: Artegraft® Collagen Vascular Graft™ (Artegraft)

Normal Access

ACTIVE COMPARATOR

Artegraft® Collagen Vascular Graft™ (Artegraft) will be accessed after 10 days as per current IFU.

Device: Artegraft® Collagen Vascular Graft™ (Artegraft)

Interventions

Artegraft® Collagen Vascular Graft™ (Artegraft) DEVICE

The Artegraft is intended for use distal to the aorta as a segmental arterial replacement, as an arterial bypass, as an arteriovenous shunt where more conventional methods have proven inadequate, or as an arterial patch graft.

Early Access; Normal Access

Eligibility Criteria

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

You may qualify if:

• Patients are eligible to be included in the study only if they meet the following criteria:
• Male or Female, 18 years or older
• Diagnosis of End Stage Renal Disease (ESRD) and require vascular access for hemodialysis
• Native \[autogenous tissue\] AV fistula creation or access is not indicated or non-viable \[disadvantaged veins\]
• Requiring repair of an existing fistula or conduit, but only if using Artegraft as an interposition placement and the Artegraft is cannulated \[not the fistula\]. Artegraft must be place in a fresh subcutaneous tunnel. Thigh loop grafts will not be used.
• Able to accommodate vascular graft placement in the upper extremity (i.e., forearm, or upper arm)
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)
• Able and willing to comply with the study protocol
• Agrees to initiate and maintain hemodialysis treatments
• Life expectancy is \> 1 year based on physician assessment

You may not qualify if:

• Patients are excluded from the trial if any of the following criteria apply:
• High grade central venous stenosis/occlusion
• Breast-feeding, pregnant or planning pregnancy within next 12 months.
• Non-resolved infected existing grafts
• Documented sepsis/bacteremia by blood culture within 4 weeks of implantation.
• History of non-controlled immunodeficiency syndrome, including AIDS/HIV; Active clinically significant immune-mediated disease, not controlled by low-dose maintenance immunosuppression. The diagnosis of HIV alone, provided adequately treated, is not a contraindication for enrolment.
• Severe liver dysfunction and/or coagulation or bleeding disorders.
• Elevated platelet count \> 1 million cells/mm3
• History of heparin-induced thrombocytopenia syndrome (HIT)
• Documented hypercoagulable state
• Currently participating in another investigational drug or device study which may clinically interfere with any endpoints of this trial
• Known hypersensitivity or contraindication to device materials or procedural medications that cannot be adequately managed medically
• History or evidence of severe cardiac disease (NYHA Functional Class III or IV), , myocardial infarction within 6 months of enrollment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina, uncontrolled CHF
• History or evidence of severe peripheral arterial disease in the extremity selected for implant (i.e. arterial inflow insufficient to support hemodialysis)
• History of cancer with active disease or treatment within the previous year, except for non-invasive basal or squamous cell carcinoma of the skin

Sponsors & Collaborators

• Artegraft, Inc.: lead

Study Sites (5)

University of California

San Diego, California, 92093, United States

Location

Capital District Renal Physicians

Albany, New York, 12209, United States

Location

Dialysis Access Institute

Orangeburg, South Carolina, 29118, United States

Location

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

City Hospital at White Rock

Dallas, Texas, 75218, United States

Location

Related Publications (7)

• Manns B, Tonelli M, Yilmaz S, Lee H, Laupland K, Klarenbach S, Radkevich V, Murphy B. Establishment and maintenance of vascular access in incident hemodialysis patients: a prospective cost analysis. J Am Soc Nephrol. 2005 Jan;16(1):201-9. doi: 10.1681/ASN.2004050355. Epub 2004 Nov 24.

  PMID: 15563567 BACKGROUND

• Pastan S, Soucie JM, McClellan WM. Vascular access and increased risk of death among hemodialysis patients. Kidney Int. 2002 Aug;62(2):620-6. doi: 10.1046/j.1523-1755.2002.00460.x.

  PMID: 12110026 BACKGROUND

• Al Shakarchi J, Inston N. Timing of cannulation of arteriovenous grafts: are we too cautious? Clin Kidney J. 2015 Jun;8(3):290-2. doi: 10.1093/ckj/sfu146. Epub 2015 Jan 20.

  PMID: 26034590 BACKGROUND

• US Renal Data System, Annual Data Report: Atlas of Chronic Kidney Disease and End Stage Renal Disease in the United States, Bethesda MD, National Institutes of Health, National Institute of Diabetes and Kidney Diseases, 2009

  BACKGROUND

• Fresenius Medical Care : Fresenious Medical Care Annual Report 2011 - Dialysis Market, Bad Homburg, Germany, Freesenious Medical Care, 2011

  BACKGROUND

• US Renal Data System: 2012 Annual Data Report : Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, Bethesda, MD, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, 2012

  BACKGROUND

• US Renal Data System: 2014 Annual Data Report : Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, Bethesda, MD, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, 2014

  BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Tony Calandra, President
• Organization: Accidentals Inc. (Formally Artegraft Inc.)

arc@mcguggan.com

973.540.1250

Study Officials

• Mahmoud Malas, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Patients will be randomized in a 2:1 ratio to either early or late vascular access. The randomization will be stratified by investigative site, and will use a random permuted block design within strata, with blocks of size 3 and 6 ordered randomly within site. Once a patient signs informed consent, is determined to meet the inclusion/exclusion criteria, and is successfully implanted with the Artegraft, the site designated staff will open an envelope to determine the randomization number and whether the patient is randomly allocated to early or late vascular access.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Artegraft will follow all study patients enrolled in the proposed clinical trial and that have successful cannulation within 72 hours as defined above, for 6 months. If follow-up is necessary at 1 year after graft implantation, it will be done via phone survey. The late-access group \[\>/= 10 days\] will be followed to 30 days post-first cannulation. If follow-up is necessary at 6 months after graft implantation, it will be done via phone survey. Day 0 is defined as the day of first cannulation, for early-access and late-access groups, to allow full follow-up to at least 30 days for both groups.

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 31, 2019
• Study Start: December 3, 2019
• Primary Completion: June 16, 2020
• Study Completion: June 16, 2020
• Last Updated: June 29, 2023
• Results First Posted: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)