Table III.
Inclusion criteria (all must be present for inclusion): 1. Age ≥ 35 years | |
2. | Popliteal artery aneurysm ≥2 cm in diameter with or without the presence of mural thrombus |
3. | Candidates for both OPEN and EPAR as judged by the enrolling investigator. |
4. | Greater than 2-cm length of normal superficial femoral artery distal to the deep femoral artery takeoff and >2-cm length of normal popliteal artery proximal to the first patent tibial artery. |
5. | Patient signs consent to participate in the trial. |
Exclusion criteria (none of these can be met for inclusion): 1. Popliteal artery thrombosis | |
2. | Popliteal artery aneurysm causing symptomatic thromboembolic disease or compressive symptoms. |
3. | Superficial femoral artery occlusion |
4. | Less than 2-cm length of normal artery to accommodate stent-graft seal |
5. | Life expectancy of less than 2 years. |
6. | Deemed excessive risk for surgical bypass (defined as prohibitive operative risk by formal preprocedural cardiac risk assessment undertaken by a cardiologist or internist according to established AHA guideline criteria). |
7. | A documented hypercoagulable state (defined as a known blood disorder associated with venous or arterial thrombosis). |
8. | Any infrainguinal revascularization procedure on index leg within 12 weeks before treatment initiation. |
9. | Current immunosuppressive medication, chemotherapy, or radiation therapy. |
10. | Absolute contraindication to iodinated contrast because of prior near-fatal anaphylactoid reaction (laryngospasm, bronchospasm, cardiorespiratory collapse, or equivalent), and which would preclude patient from participating in angiographic procedures. |
11. | Allergy to stainless steel or nitinol. |
12. | Pregnancy or lactation. |
13. | Inability or refusal to provide informed consent. |
AHA, American Heart Association.