BIOTRONIK Dynetic-35 Stent for the Treatment of Peripheral Iliac Lesions

Prospective, international, multi-center, single-arm study with up to 60 months follow up to evaluate safety and effectiveness of BIOTRONIK's Dynetic-35 stent associated with the use of Passeo-35 Xeo for the treatment of peripheral artery disease (PAD) in subjects with atherosclerotic disease in iliac arteries

Inclusion criteria

• Subject is ≥ 18 years or the minimum age required for legal adult consent in the country of enrolment
• 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
• De novo, restenotic or occluded lesion(s) representing atherosclerotic lesion(s) in the iliac arteries
• Reference lumen (vessel) diameter between 5mm and 10mm
• The target lesion can be successfully crossed with a guide wire
• The target lesion length is ≤ 100 mm
• Subjects has more than 70% stenosis in target lesion
• Subject has an evidence of a patent profunda femoris or superficial femoral artery in the target limb
• Subject has symptomatic iliac artery occlusive disease defined as Rutherford category 2 or higher eligible for stenting

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
• Refuses blood transfusion
• Chronic renal insufficiency (Serum creatinine >2.5 mg/dL within 30 days prior to index procedure)
• Subject has IFU listed contraindication(s)
• Subject has in-stent restenosis