Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Vascular Graft Solutions Ltd.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Patient scheduled for infrainguinal peripheral artery bypass surgery with single segment autogenous saphenous vein.
2. Rutherford classification 3-6
3. Adequate revascularization target defined as an infrainguinal arterial segment distal to the area of stenosis/occlusion which can support a distal anastomosis of a surgical bypass.
4. Patient is able and willing to give their informed written consent.
5. Patient is able and willing to comply with study follow up requirements.
6. Patient is ≥ 18 years of age
You may not be if
1. Patients indicated for endovascular treatment
2. Prior surgical bypass procedure in ipsilateral lower limb.
3. Active ulcer/infection/gangrene at the intended distal anastomosis site.
4. Severe vein varicosity
5. Saphenous vein with external pressurized diameter of less than 3.5 mm or more than 8 mm.
6. Spliced vein technique
7. In-situ vein technique
8. Pedal/plantar distal anastomosis
9. Planned above ankle amputation on ipsilateral limb within 4 weeks of index procedure.
10. Patients with history of hypercoagulable conditions.
11. Patients with significant stenoses distal to the planned anastomotic site and any other known conditions that could adversely affect graft patency.
12. Concomitant life-threatening disease likely to limit life expectancy to less than 2 years.
13. Contraindication to recommended study medications
14. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
