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

End Stage Renal Disease Clinical Trial

Official title:

Clinical Evaluation of a Vascular Venous Anastomotic Connector for Minimally Invasive Connection of an Arteriovenous Graft for Hemodialysis [InterGraft VIG-only Study]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02532621
• Other study ID #: Venous Anastomotic Connector
• Status: Completed
• Phase: N/A
• Start date: February 21, 2018
• Est. completion date: January 19, 2022

Study information

• Verified date: December 2023
• Source: Phraxis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The InterGraft™ Venous Anastomotic Connector (VIG) was developed for endovascular, minimally invasive venous anastomosis of a standard arteriovenous graft (AVG) for hemodialysis. This study will evaluate the safety and performance of the VIG for anastomosis of a commercially available, 6 mm diameter, synthetic AVG. Anastomoses with the VIG may potentially reduce venous vessel trauma, improve the local vessel wall shear stresses and promote laminar flow, thereby improving patency.

While recognizing that a native fistula is the recommended access for hemodialysis, AVGs remain a frequently used access type. This study focuses on subjects who have a failed fistula, cannot have a fistula or are better suited for an AVG, as determined by the physician. The implant procedural outcomes, the number and type of major adverse events, and patency throughout a six-month follow-up period will be evaluated. The six-month patency rate will be compared with a pre-specified patency performance goal drawn from surgical AVG literature and published performance standards.

This is a pivotal, multicenter, prospective, non-randomized design study. All enrolled subjects will receive the VIG device and will have a standard sutured arterial anastomosis.

A total of 158 evaluable subjects will be enrolled, defined as primary analysis population of 146 subjects plus allowance for 12 subjects lost-to-follow up.

The study includes10 participating clinical centers. Study site investigators are physicians skilled in AVG placement and interventional techniques. Study data will be collected up to the point at which each subject has completed the six-month endpoint or experienced a terminal study endpoint.

The study will be conducted in compliance with the Investigational Plan, Investigational Device Exemption regulations, Good Clinical Practice guidelines, and other applicable regulatory requirements.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: January 19, 2022
• Est. primary completion date: January 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject is = 18 years of age.

2. Subject requires the creation of a vascular access graft for hemodialysis, secondary to a diagnosis of End Stage Renal Disease.

3. Subject is able to have the vascular access graft placed in an upper extremity.

4. 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.

5. Subject has a reasonable expectation of remaining on hemodialysis for at least 6 months.

6. Subject or his/her legal guardian understands the study and is willing and able to comply with the dialysis schedule and follow-up requirements.

7. 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.

8. 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.

Exclusion Criteria:

1. Subject has a documented and unsuccessfully treated ipsilateral central venous stenosis as determined by imaging.

2. 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.

3. 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.

4. Subject has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known sensitivity to heparin.

5. Subject has co-morbid conditions that may limit their ability to comply with study and follow-up requirements.

6. The patient has had >2 previous arteriovenous accesses in treatment arm.

7. Subject is currently taking Aggrenox®.

8. Subject is in need of, or is scheduled for any major surgery within 30 days of the study procedure.

9. Subject is currently taking maintenance immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone (>10 mg), cyclosporine, tacrolimus or cyclophosphamide.

10. Life expectancy is less than 12 months.

11. 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.

12. Subject is a poor compliance risk (i.e. history of IV or oral drug abuse).

13. The subject is enrolled in another dialysis or vascular investigational study.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Device:
• Venous InterGraft Connector
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.

Procedure:
• sutured arterial anastomosis of an implanted vascular graft for hemodialysis
The arterial anastomosis of the implanted vascular graft for hemodialysis is formed using standard suturing technique.
• hemodialysis
The implanted vascular graft is intended as a vascular access for performing hemodialysis treatments.

Locations

Country	Name	City	State
United States	Cartersville Medical Center, LLC	Cartersville	Georgia
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Surgical Specialists of Charlotte	Charlotte	North Carolina
United States	Henry Ford Health System- Dept of Surgery	Detroit	Michigan
United States	Triad of Alabama/Flowers Hospital	Dothan	Alabama
United States	McLeod Physician Associates II	Florence	South Carolina
United States	Medical Center of Central Georgia - Navicent Health	Macon	Georgia
United States	Regional Medical Center of Orangeburg and Calhoun Counties	Orangeburg	South Carolina
United States	Saint Louis University	Saint Louis	Missouri
United States	Spartanburg Regional Medical Center	Spartanburg	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Phraxis, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (8)

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

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 he — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Patency	Percentage of subjects free from loss of access of the study graft for hemodialysis	Six Months
Secondary	Acute device success	AV graft flow at end of implant procedure	24 hours
Secondary	Primary unassisted patency	Percentage of subjects free from the occurrence of either access thrombosis or an access procedure performed to maintain access patency	Six months
Secondary	Time to first cannulation	Time from initial access placement to first graft cannulation for hemodialysis	Six months
Secondary	Interventions required to maintain patency	Number and type of interventions required to maintain secondary patency	Six months
Secondary	Serious Adverse Events	Number and type of serious adverse events- death, emergent surgery, significant bleeding,graft infection, pseudoaneurysm	Six months