Peripheral Arterial Disease, Peripheral Artery Disease
Conditions
Keywords
Saphenous vein graft, PAD, Peripheral bypass surgery, external support
Brief summary
30 patients will be enrolled in a prospective, multi-center, one-arm study, enrolling patients with claudication and chronic limb ischemia scheduled for lower limb venous bypass grafting on clinical grounds with single segment autologous saphenous vein. Subjects will be followed for 5 years, with follow up visits at 1, 3, 6, 12 months, 2, 3, 4, 5, years post operation.
Interventions
DEVICEFRAME
External support for vein grafts in peripheral bypass surgery
Sponsors
Vascular Graft Solutions Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency | 12 months | Freedom of vein graft from occlusion and clinically driven target lesion revascularization as measured by Doppler Ultrasound |
Countries
United States
Outcome results
None listed