CSP-2002 Intervention Guidelines
Clinical Protocol: CSP-2002
The InnAVasc Arteriovenous Graft (IG) is being evaluated in an investigational study (CSP-2002) to evaluate the safety and effectiveness of the IG for its intended use.
IMPORTANT:
PRIOR TO PERFORMING ANY INTERVENTIONS on the IG during this investigational study, communicate with one of the following: the clinical site Principal Investigator (PI), the overall Study PI, or the Study Sponsor.
Position | Contact | Phone | |
---|---|---|---|
Overall Study PI | John Ross, MD | +1 803-707-6252 | jrrsurgery@aol.com |
Study Sponsor (Product Specialist) | Zach Crannell | +1 972-890-3762 | zcrannel@wlgore.com |
During the follow-up period, in the event of IG occlusion or poor performance, established vascular access revision procedures should be followed per these brief guidelines. Appropriate revision procedure selection should be determined by the surgical or interventional team based on the specific case requirements.
How to Identify the Pod
For general orientation, begin by identifying the two cannulation pods by manual palpation of the InnAVasc Graft. It is helpful to palpate the ends and the sides of each pod to isolate the position/location of each.
Thrombectomy
When performing an open thrombectomy procedure on the InnAVasc Graft, it is important to expose the graft lateral to the cannulation pod (between the pod and venous anastomosis, or between pod and arterial anastomosis).