FLUENCY® PLUS Endovascular Stent Graft for In-stent Restenosis

Exclusion Criteria

• •The target lesion has had a corresponding thrombosis treated within 7 days prior to the index procedure.
• •The target lesion has a reference vessel diameter that is larger than 12.0 mm.
• •The patient has an infected AV access graft/fistula or uncontrolled systemic infection.
• •A pseudoaneurysm is present within the target lesion.
• •The location of the target lesion would require that the FLUENCY® PLUS Endovascular Stent Graft be deployed across the elbow joint.
• •The location of the target lesion would require that the FLUENCY® PLUS Endovascular Stent Graft be deployed at or across the segment of graft or fistula utilized for dialysis needle puncture (i.e., "cannulation zone").
• •The location of the target lesion would require that the FLUENCY® PLUS Endovascular Stent Graft cross the cephalic arch (perpendicular portion of the cephalic vein in the region of the deltopectoral groove before its junction with the axillary vein).
• •The location of the target lesion would require that the FLUENCY® PLUS Endovascular Stent Graft be placed in the Superior Vena Cava.
• •The location of the target lesion would require that the FLUENCY® PLUS Endovascular Stent Graft is placed across an angle that is greater than 90 degrees.
• •The restenosed bare metal stent is fractured, as verified by angiography per institution's standard of care.
• •The patient has a known uncontrolled blood coagulation disorder.
• •The patient has a known allergy or sensitivity to contrast media which cannot be adequately pre-medicated.
• •The patient has a known hypersensitivity to nickel-titanium.
• •The subject has another medical condition, which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up.
• •The patient is currently participating in an investigational drug or another device study that has not completed the study treatment or that clinically interferes with the study endpoints. Note: Studies requiring extended follow-up visits for products that were investigational, but have since become commercially available, are not considered investigational studies.