Arteriovenous Fistula Stenosis, Arteriovenous Graft Stenosis, Peripheral Artery Disease
Conditions
Brief summary
Evaluation of the FLEX Vessel Prep system combined with angioplasty in the treatment of arteriovenous access stenosis.
Interventions
DEVICEFLEX Vessel Prep System followed by angioplasty
Eligible Arteriovenous Fistula (AVF)/Arteriovenous Graft (AVG) will be treated with the FLEX Vessel Prep system followed by angioplasty.
Sponsors
VentureMed Group Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Hemodialysis patient currently scheduled to undergo an intervention of their arteriovenous fistula or graft due to clinical or hemodynamic abnormalities. 2. The patient is ≥18 years of age. Patient is legally competent, has been informed of the study, voluntarily agrees to participate, and has signed the inform consent form. 3. The patient has a reasonable expectation of remaining on hemodialysis for 12 months. 4. The patient understands the study and is willing and able to comply with follow-up requirements. 5. The patient is willing to provide informed consent.
Exclusion criteria
1. The patient has a known or suspected systemic infection. 2. The patient has a known or suspected infection of the hemodialysis graft. 3. The patient has an untreatable allergy to radiographic contrast material. 4. In the opinion of the operating physician, the patient's hemodialysis access is unsuitable for endovascular treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anatomic Success | At the completion of the index procedure | Defined as the angiographic percentage of stenosis post procedure as \<30% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success | 6 Months | The resumption of normal dialysis for at least one session. |
| Procedural Success | 6 Months | Composite of anatomic and clinical success |
| Target Lesion Primary Patency | 6, 9 and 12 Months | The time interval of uninterrupted patency from initial study treatment to the next thrombosis or intervention performed on the target lesion |
| Technical Success of the Device | At the index procedure | Delivery to the target lesion, deployment of the treatment element, and retrieval |
| Assisted Primary Patency | 6, 9, and 12 Months | The time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit. |
| Access Secondary Patency | 6, 9, and 12 Months | The time interval from initial study treatment to abandonment of the vascular access circuit. |
| Circuit Primary Patency | 6, 9, and Months | The time interval from initial study treatment to the next access thrombosis or intervention performed within the vascular access circuit. |
Countries
United States
Outcome results
None listed