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

Not Applicable

Completed

• Conditions: End Stage Renal Disease
• Interventions: Device: Venous InterGraft Connector; Procedure: sutured arterial anastomosis of an implanted vascular graft for hemodialysis; Procedure: hemodialysis

• Registration Number: NCT02532621
• Lead Sponsor: Phraxis, Inc.

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-08-19
• Study First Submitted QC: 2015-08-21
• Study First Posted: 2015-08-26
• Study Start: 2018-02-21
• Primary Completion: 2022-01-19
• Study Completion: 2022-01-19
• Disposition First Submitted: 2022-09-07
• Disposition First Submitted QC: 2022-09-07
• Disposition First Posted: 2022-09-13
• Results First Submitted: 2024-12-10
• Results First Submitted QC: 2024-12-10
• Status Verified: 2025-01
• Results First Posted: 2025-01-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Venous InterGraft Connector (VIG)	Venous InterGraft Connector	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.
Venous InterGraft Connector (VIG)	hemodialysis	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.
Venous InterGraft Connector (VIG)	sutured arterial anastomosis of an implanted vascular graft for hemodialysis	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.

Primary Outcome Measures

Name	Time	Method
Cumulative Patency at 6 Months	Six months of clinical follow-up following treatment assignment (enrollment)	Percentage of subjects free from loss of access of the study graft for hemodialysis

Secondary Outcome Measures

Name	Time	Method
Acute Device Success	24 hours	AV graft flow at end of implant procedure
Primary Unassisted Patency	Six months	Percentage of subjects free from the occurrence of either access thrombosis or an access procedure performed to maintain access patency
Time to First Cannulation	Six months	Time from initial access placement to first graft cannulation for hemodialysis
Interventions Required to Maintain Patency	Six months	Number of interventions required to maintain secondary patency
Serious Adverse Events (Secondary Endpoint Defined SAEs)	Six months	Number and type of serious adverse events- death, emergent surgery, significant bleeding,graft infection, pseudoaneurysm

Trial Locations

Locations (10)

Triad of Alabama/Flowers Hospital; 🇺🇸 Dothan, Alabama, United States

Spartanburg Regional Medical Center; 🇺🇸 Spartanburg, South Carolina, United States

Saint Louis University; 🇺🇸 Saint Louis, Missouri, United States

Cartersville Medical Center, LLC; 🇺🇸 Cartersville, Georgia, United States

Medical Center of Central Georgia - Navicent Health; 🇺🇸 Macon, Georgia, United States

Surgical Specialists of Charlotte; 🇺🇸 Charlotte, North Carolina, United States

McLeod Physician Associates II; 🇺🇸 Florence, South Carolina, United States

Henry Ford Health System- Dept of Surgery; 🇺🇸 Detroit, Michigan, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Regional Medical Center of Orangeburg and Calhoun Counties; 🇺🇸 Orangeburg, South Carolina, United States