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

Study Overview
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Brief Summary
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BIOTRONIK cobalt chromium balloon-expandable Dynetic-35 stent in association with Passeo-35 Xeo peripheral dilation catheter for the treatment of peripheral iliac lesions

Detailed Description
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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

Official Title
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BIOTRONIK Dynetic-35 for the Treatment of Peripheral Iliac Lesions, Using the Cobalt Chromium Balloon-expandable Dynetic-35 Stent in Association With Passeo-35 Xeo Peripheral Dilation Catheter

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Device: Ballon expandable stent and PTA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Ballon expandable stent and PTA|Endovascular treatment for the peripheral artery disease of the Iliac artery|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MAE at 12 months post-index procedure. | The MAE includes device or procedure related death within 30 days post index procedure, cdTLR, and major index limb amputation up to 12 months post index procedure. | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iliac arteries