Table III.
Inclusion and exclusion criteria for OVERPAR trial
| 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.