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:

1. Subject is ≥ 18 years

2. Subject is capable (no legally authorized representative allowed) to provide writteninformed consent as approved by the Institutional Review Board (IRB)/EthicsCommittee (EC) of the respective clinical site prior to any study related procedure

3. Subject has provided written informed consent before any study specific test orprocedure and is willing to comply with all protocol and follow-up requirements

4. Subjects have a target lesion(s) with ≥ 70% stenosis (visual estimate) located inthe iliac arteries

5. Target lesion is a de novo, restenotic or occluded lesion

6. Reference lumen (vessel) diameter between 5mm and 10 mm

7. The target lesion can be successfully crossed with a guide wire

8. Patient is eligible for transradial access

9. Subject has symptomatic iliac artery disease defined as Rutherford category 2 orhigher

Exclusion Criteria:

1. Subject is pregnant and/or breastfeeding or planning to become pregnant during thecourse of the study.

2. Subject is with a current medical condition with a life expectancy of less than oneyear.

3. Pre-existing target iliac artery aneurysm or perforation or dissection

4. Any medical condition that in the opinion of the investigator poses an unacceptablerisk for implant of a stent according to the study indications like, sensitivity tometal ions, intolerance to contrast or antiplatelet, anticoagulant or thrombolyticmedications required per the protocol

5. Abdominal aortic aneurysm (AAA) contiguous to the iliac artery target lesionrequiring treatment

6. The subject is currently participating in an investigational drug, biologic, oranother device study and has not reached their primary endpoint yet

7. Subjects with small diameter upper extremity arteries that posed a contraindicationto 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 indexprocedure

12. Patients with negative bilateral Allen or barbeau tests (Note: vascular accessshould be done via the left hand where possible)

13. Subject has IFU listed contraindication(s)

14. Subject has in-stent restenosis