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

Inclusion criteria

• Subject is ≥ 18 years
• Subject is capable (no legally authorized representative allowed) to provide written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site prior to any study related procedure
• Subject has provided written informed consent before any study specific test or procedure and is willing to comply with all protocol and follow-up requirements
• Subjects have a target lesion(s) with ≥ 70% stenosis (visual estimate) located in the iliac arteries
• Target lesion is a de novo, restenotic or occluded lesion
• Reference lumen (vessel) diameter between 5mm and 10 mm
• The target lesion can be successfully crossed with a guide wire
• Patient is eligible for transradial access
• Subject has symptomatic iliac artery disease defined as Rutherford category 2 or higher

Exclusion criteria

• Subject is pregnant and/or breastfeeding or planning to become pregnant during the course of the study.
• Subject is with a current medical condition with a life expectancy of less than one year.
• Pre-existing target iliac artery aneurysm or perforation or dissection
• 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
• Abdominal aortic aneurysm (AAA) contiguous to the iliac artery target lesion requiring treatment
• The subject is currently participating in an investigational drug, biologic, or another device study and has not reached their primary endpoint yet
• Subjects with small diameter upper extremity arteries that posed a contraindication to the use of 6F sheath
• Severe stenosis or calcification of upper extremity arteries
• Patient height precluding transradial access with a 170 cm long catheter shaft
• Patient with a history of aortic arch atheroembolism
• Infrainguinal outflow lesions that need to be treated during the same index procedure
• Patients with negative bilateral Allen or barbeau tests (Note: vascular access should be done via the left hand where possible)
• Subject has IFU listed contraindication(s)
• Subject has in-stent restenosis