An Investigator Initiated Trial to Evaluate the Safety and Feasibility of the DyNETIC-35 Stent for Iliac Lesions Via a Trans-radial Approach

Exclusion Criteria

• •1. Subject is pregnant and/or breastfeeding or planning to become pregnant during the course of the study.
• •2. Subject is with a current medical condition with a life expectancy of less than one year.
• •3. Pre-existing target iliac artery aneurysm or perforation or dissection
• •4. Any medical condition that in the opinion of the investigator poses an unacceptable risk for implant of a stent according to the study indications like, sensitivity to metal ions, intolerance to contrast or antiplatelet, anticoagulant or thrombolytic medications required per the protocol
• •5. Abdominal aortic aneurysm (AAA) contiguous to the iliac artery target lesion requiring treatment
• •6. The subject is currently participating in an investigational drug, biologic, or another device study and has not reached their primary endpoint yet
• •7. Subjects with small diameter upper extremity arteries that posed a contraindication to the use of 6F sheath
• •8. Severe stenosis or calcification of upper extremity arteries
• •9. Patient height precluding transradial access with a 170 cm long catheter shaft
• •10. Patient with a history of aortic arch atheroembolism
• •11. Infrainguinal outflow lesions that need to be treated during the same index procedure
• •12. Patients with negative bilateral Allen or barbeau tests (Note: vascular access should be done via the left hand where possible)
• •13. Subject has IFU listed contraindication(s)
• •14. Subject has in-stent restenosis