GORE PROPATEN Vascular Graft vs. Disadvantaged Autologous Vein Graft

Comparison of Primary Patency Between GORE PROPATEN Vascular Graft and Disadvantaged Autologous Vein Graft For Below-Knee Arterial Bypass (PRODIGY Study)

The primary patency of the GORE PROPATEN Vascular Graft is equivalent to or better than disadvantaged autologous vein graft in an infragenicular peripheral bypass application at 12 months.

Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow. A disadvantaged autologous vein is defined as meeting at least one of the two following criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator; (2) Usable ipsilateral or contralateral autologous greater saphenous vein that meets any of the following criteria: (a) Diameter of less than or equal to 3.0 mm; (b) Inadequate length requiring splicing; (c) Poor quality vein that is either sclerotic or phlebitic.

Inclusion Criteria:

1. Patient requires below-knee bypass secondary to severe claudication, rest pain or tissue loss due to peripheral arterial occlusive disease.
2. Patient meets the disadvantaged autologous vein criteria described in Section 4.1.
3. Patient has a post-operative life expectancy greater than one year.
4. Patient is at least 21 years of age.
5. Patient is able to comply with all study requirements and be available for follow-up visits at 1, 6, 12, 24 and 36-months post-procedure.
6. Patient is willing and able to provide written, informed consent.

Exclusion Criteria:

1. Patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known hypersensitivity to heparin.
2. Patient requires an infragenicular bypass for reasons other than peripheral arterial occlusive disease.
3. Patient requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts.
4. Patient is in need of, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure within 30 days of study procedure. However, inflow procedures that facilitate the bypass are permitted, as long as they are not performed at the same sitting as the bypass procedure.
5. Patient has been previously randomized for this study.
6. Patient has active infection in the region of graft placement.