Clinical Evaluation of a Vascular Venous Anastomotic Connector

The InterGraft™ Venous Anastomotic Connector (VIG) was developed for minimally invasive
venous anastomosis of a standard hemodialysis graft. This study will evaluate the safety and
performance of the VIG for anastomosis of a commercially available, 6 mm diameter, ePTFE
hemodialysis graft. Anastomoses with the VIG may potentially reduce venous vessel trauma,
improve the local vessel wall shear stresses and promote laminar flow, thereby improving
patency. The available InterGraft™ Arterial Anastomotic Connector (AIG) will also be used
during the study in a subgroup of suitably qualified subjects for purposes of additional data
collection.

While recognizing that a native fistula is the recommended access for hemodialysis, AV grafts
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 AV graft, as determined by the
physician. The graft implant procedural outcomes, the number and type of major adverse
events, and patency throughout a six (6) month follow-up period will be evaluated. The
6-month patency rate will be compared with a pre-specified patency performance goal that is
drawn from prior surgical AV graft literature and published performance standards.10, 14-20

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

This is a pivotal multicenter, prospective, non-randomized adaptive design study. The planned
study enrollment is 104 evaluable subjects who require AV graft placement for hemodialysis
and who meet the entry criteria. The subjects will receive the VIG device and will have
either a standard sutured arterial anastomosis or have received an AIG device for the
arterial anastomosis (VIG-AIG subgroup). This number may be expanded following a planned
interim analysis to up to 185 evaluable subjects for the primary study evaluation.

The study will allow for a maximum enrollment of 227 subjects, including a provision for 12
subjects lost to follow-up and up to 30 roll-in cases. Roll-in subjects will not be included
in the primary analysis but will be analyzed separately.

The study will include up to 15 participating clinical centers. Study site investigators will
be physicians skilled in AV access graft placement and interventional techniques. Study data
will be collected up to the point at which each subject has completed the 6-month endpoint.

VIG-AIG Subgroup All study subjects will receive the VIG device. A subgroup of previously
enrolled subjects receiving the VIG device will also have received an AIG device for the
arterial anastomosis, rather than a sutured arterial anastomosis. This group is referred to
as the "VIG-AIG Subgroup."

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.