Clinical Evaluation of a Vascular Venous Anastomotic Connector [InterGraft VIG-only Study]

NCT02532621 | Completed Results DMC FDA Device

• 1 other identifier: Venous Anastomotic Connector
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 10

Brief Summary

The InterGraft™ Venous Anastomotic Connector provides an endovascular, minimally invasive means for attachment of an arteriovenous graft to a vein in the upper extremity. The InterGraft™ Venous Anastomotic Connector facilitates creation of the arteriovenous graft connection to a vein in support of hemodialysis in subjects with End Stage Renal Disease. The InterGraft™ Venous Anastomotic Connector is used together with conventional suturing of the arterial anastomosis to facilitate creation of an arteriovenous graft in support of hemodialysis in subjects with End Stage Renal Disease.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• Cumulative Patency at 6 Months

  Percentage of subjects free from loss of access of the study graft for hemodialysis

  Six months of clinical follow-up following treatment assignment (enrollment)

Secondary Outcomes (5)

• Acute Device Success

  24 hours

• Primary Unassisted Patency

  Six months

• Time to First Cannulation

  Six months

• Interventions Required to Maintain Patency

  Six months

• Serious Adverse Events (Secondary Endpoint Defined SAEs)

  Six months

Study Arms (1)

Venous InterGraft Connector (VIG)

EXPERIMENTAL

This is a nonrandomized, single-arm study: All enrolled patients are assigned to the same treatment: AVG implantation using a VIG (study device) to create the venous anastomosis and standard suturing to create the arterial anastomosis of the implanted AVG.

Device: Venous InterGraft Connector; Procedure: sutured arterial anastomosis of an implanted vascular graft for hemodialysis; Procedure: hemodialysis

Interventions

Venous InterGraft Connector DEVICE

The device is designed for transcatheter delivery within a vein and connection to an AVG that has been tunneled under the skin in a standard manner. The connection is made via a small skin incision.

Also known as: VIG

Venous InterGraft Connector (VIG)

sutured arterial anastomosis of an implanted vascular graft for hemodialysis PROCEDURE

The arterial anastomosis of the implanted vascular graft for hemodialysis is formed using standard suturing technique.

Venous InterGraft Connector (VIG)

hemodialysis PROCEDURE

The implanted vascular graft is intended as a vascular access for performing hemodialysis treatments.

Venous InterGraft Connector (VIG)

Eligibility Criteria

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

You may qualify if:

• Subject is ≥ 18 years of age.
• Subject requires the creation of a vascular access graft for hemodialysis, secondary to a diagnosis of End Stage Renal Disease.
• Subject is able to have the vascular access graft placed in an upper extremity.
• Baseline imaging shows suitable vascular anatomy/ vessel size for the InterGraft™ Venous Connector and an artery at least 3.5 mm in diameter that is suitable for creating the arterial anastomosis.
• Subject has a reasonable expectation of remaining on hemodialysis for at least 6 months.
• Subject or his/her legal guardian understands the study and is willing and able to comply with the dialysis schedule and follow-up requirements.
• Subject or his/her legal guardian provides written informed consent. NOTE: In accordance with the requirements of some Institutional Review Boards, where applicable, only those subjects with capacity to consent for themselves will be included. Thus, where required by the Institutional Review Board, adult individuals who lack capacity to consent for themselves will be excluded from the study.
• Physician's examination at time of surgery shows no significant vessel lesions, calcification(s), anatomic structures or abnormalities that may limit ability to safely deploy the InterGraft Connectors or create a sutured arterial anastomosis.

You may not qualify if:

• Subject has a documented and unsuccessfully treated ipsilateral central venous stenosis as determined by imaging.
• Subject currently has a known or suspected bacterial, fungal, or HIV infection. NOTE: Patients with hepatitis B or C may be included in the study.
• Subject has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.
• NOTE: The intent of this criterion is to exclude patients with high risk for bleeding or clotting complications. As such, patients who are taking oral anticoagulants (blood thinners) including, but not limited to, Xarelto® (rivaroxaban) or Eliquis® (apixaban) should also be excluded from the study. Patients may receive anticoagulation therapy any time after the study AV graft implant procedure, at their physician's discretion. This should be driven by an indication unrelated to the vascular access.
• Subject has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known sensitivity to heparin.
• Subject has co-morbid conditions that may limit their ability to comply with study and follow-up requirements.
• The patient has had \>2 previous arteriovenous accesses in treatment arm.
• Subject is currently taking Aggrenox®.
• Subject is in need of, or is scheduled for any major surgery within 30 days of the study procedure.
• Subject is currently taking maintenance immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone (\>10 mg), cyclosporine, tacrolimus or cyclophosphamide.
• Life expectancy is less than 12 months.
• Subject is pregnant. NOTE: A negative urine pregnancy test within 24 hours of the study procedure is required in all female subjects with reproductive capacity.
• Subject is a poor compliance risk (i.e. history of IV or oral drug abuse).
• The subject is enrolled in another dialysis or vascular investigational study.

Sponsors & Collaborators

• Phraxis, Inc.: lead

Study Sites (10)

Triad of Alabama/Flowers Hospital

Dothan, Alabama, 36305, United States

Location

Cartersville Medical Center, LLC

Cartersville, Georgia, 30120, United States

Location

Medical Center of Central Georgia - Navicent Health

Macon, Georgia, 31201, United States

Location

Henry Ford Health System- Dept of Surgery

Detroit, Michigan, 48202, United States

Location

Saint Louis University

St Louis, Missouri, 63103, United States

Location

Surgical Specialists of Charlotte

Charlotte, North Carolina, 28207, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

McLeod Physician Associates II

Florence, South Carolina, 29506, United States

Location

Regional Medical Center of Orangeburg and Calhoun Counties

Orangeburg, South Carolina, 29118-1498, United States

Location

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Related Publications (9)

• U.S. Renal Data System. USRDS 2011 Annual Data Report: Volume 2. Atlas of End Stage Renal Disease in the United States. Bethesda, MD, National Institutes of Health, National Institutes of Diabetes, and Digestive and Kidney Diseases; 2011

  BACKGROUND

• Dember LM, Beck GJ, Allon M, Delmez JA, Dixon BS, Greenberg A, Himmelfarb J, Vazquez MA, Gassman JJ, Greene T, Radeva MK, Braden GL, Ikizler TA, Rocco MV, Davidson IJ, Kaufman JS, Meyers CM, Kusek JW, Feldman HI; Dialysis Access Consortium Study Group. Effect of clopidogrel on early failure of arteriovenous fistulas for hemodialysis: a randomized controlled trial. JAMA. 2008 May 14;299(18):2164-71. doi: 10.1001/jama.299.18.2164.

  PMID: 18477783 BACKGROUND

• Akoh JA. Prosthetic arteriovenous grafts for hemodialysis. J Vasc Access. 2009 Jul-Sep;10(3):137-47. doi: 10.1177/112972980901000301.

  PMID: 19670164 BACKGROUND

• Roy-Chaudhury P, Kelly BS, Zhang J, Narayana A, Desai P, Melham M, Duncan H, Heffelfinger SC. Hemodialysis vascular access dysfunction: from pathophysiology to novel therapies. Blood Purif. 2003;21(1):99-110. doi: 10.1159/000067863.

  PMID: 12596755 BACKGROUND

• Lee T, Roy-Chaudhury P. Advances and new frontiers in the pathophysiology of venous neointimal hyperplasia and dialysis access stenosis. Adv Chronic Kidney Dis. 2009 Sep;16(5):329-38. doi: 10.1053/j.ackd.2009.06.009.

  PMID: 19695501 BACKGROUND

• Lok CE, Allon M, Moist L, Oliver MJ, Shah H, Zimmerman D. Risk equation determining unsuccessful cannulation events and failure to maturation in arteriovenous fistulas (REDUCE FTM I). J Am Soc Nephrol. 2006 Nov;17(11):3204-12. doi: 10.1681/ASN.2006030190. Epub 2006 Sep 20.

  PMID: 16988062 BACKGROUND

• Lee HW, Allon M. When should a patient receive an arteriovenous graft rather than a fistula? Semin Dial. 2013 Jan-Feb;26(1):6-10. doi: 10.1111/sdi.12040. Epub 2012 Nov 22.

  PMID: 23173947 BACKGROUND

• Saran R, Robinson B, Abbott KC, Agodoa LY, Albertus P, Ayanian J, Balkrishnan R, Bragg-Gresham J, Cao J, Chen JL, Cope E, Dharmarajan S, Dietrich X, Eckard A, Eggers PW, Gaber C, Gillen D, Gipson D, Gu H, Hailpern SM, Hall YN, Han Y, He K, Hebert H, Helmuth M, Herman W, Heung M, Hutton D, Jacobsen SJ, Ji N, Jin Y, Kalantar-Zadeh K, Kapke A, Katz R, Kovesdy CP, Kurtz V, Lavalee D, Li Y, Lu Y, McCullough K, Molnar MZ, Montez-Rath M, Morgenstern H, Mu Q, Mukhopadhyay P, Nallamothu B, Nguyen DV, Norris KC, O'Hare AM, Obi Y, Pearson J, Pisoni R, Plattner B, Port FK, Potukuchi P, Rao P, Ratkowiak K, Ravel V, Ray D, Rhee CM, Schaubel DE, Selewski DT, Shaw S, Shi J, Shieu M, Sim JJ, Song P, Soohoo M, Steffick D, Streja E, Tamura MK, Tentori F, Tilea A, Tong L, Turf M, Wang D, Wang M, Woodside K, Wyncott A, Xin X, Zang W, Zepel L, Zhang S, Zho H, Hirth RA, Shahinian V. US Renal Data System 2016 Annual Data Report: Epidemiology of Kidney Disease in the United States. Am J Kidney Dis. 2017 Mar;69(3 Suppl 1):A7-A8. doi: 10.1053/j.ajkd.2016.12.004. No abstract available.

  PMID: 28236831 BACKGROUND

• Burgess JS, Beaver JD, London M, Rohan V, Orland P, Yevzlin A, Setum C, Ross J; InterGraft Study Investigators. Prospective multicenter study of a novel endovascular venous anastomotic procedure and device for implantation of an arteriovenous graft for hemodialysis. J Vasc Access. 2024 Jul;25(4):1244-1251. doi: 10.1177/11297298231159691. Epub 2023 Mar 9.

  PMID: 36895157 RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Renal Dialysis

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Sorption Detoxification

Limitations and Caveats

The study had the usual limitations associated with a non-randomized investigation, and this was mitigated by use of the robust historical literature to define the 6-month patency PG.

Results Point of Contact

• Title: Cindy Setum, PhD
• Organization: Phraxis, Inc.

csetum@phraxis.com

612-801-6730

Study Officials

• Cindy M Setum, Ph.D

  Phraxis, Inc.

  STUDY DIRECTOR

• John R Ross, M.D.

  Regional Medical Center

  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: August 19, 2015
• First Posted: August 26, 2015
• Study Start: February 21, 2018
• Primary Completion: January 19, 2022
• Study Completion: January 19, 2022
• Last Updated: February 6, 2025
• Results First Posted: January 1, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)