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. Author manuscript; available in PMC: 2015 Feb 3.
Published in final edited form as: Ann Vasc Surg. 2014 Oct 12;29(2):278–285. doi: 10.1016/j.avsg.2014.08.007

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.