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

Study Overview
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Brief Summary
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This feasibility study with a 30 day follow up period will assess the safety and feasibility of the Dynetic-35 stent for the treatment of peripheral iliac artery lesions via a trans-radial approach.

Official Title
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An Investigator Initiated Trial to Evaluate the Safety and Feasibility of the DyNETIC-35 Cobalt Chromium Balloon-expandable Stent for the Treatment of Atherosclerotic Iliac Lesions Via a Trans-radial Approach - Bionetic-TRA

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: Dynetic-35 Peripheral Balloon-Expandable Stent System


Participation Criteria
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Eligibility Criteria
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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

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: Dynetic-35 Peripheral Balloon-Expandable Stent System|Stenotic iliac lesions will be treated with the Dynetic 35 stent via a radial access|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Access site complications | bleeding, , pseudoaneurysm, arteriovenous fistula (AVF), radial artery rupture or occlusion | 1 hour post procedure | 
| Stroke |  | 30 days | 
| Death |  | 30 days | 
| Transradial technical success | Successful delivery of the Dynetic-35 stent at the lesion site with residual stenosis of ≤ 30% | Immediately after stent placement via radial access | 
| Number of patients converting to femoral artery access | Transradial access feasibility is assessed as number of patients in whom access is converted to femoral artery access due to failure to access the lesion via the radial artery | 1 hour post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay [hours] |  | up to 30 days | 
| Procedure time [min] |  | Intraoperative | 
| Procedure cost | Number and details of auxiliary devices and medication used | 1 hour post procedure | 
| Time to ambulation | Time between patient left the cath lab/operating theatre, and patient was able to walk 100 meters and the access site remained stable | up to 30 days | 
| Patient satisfaction regarding access site | Patient questionnaire assessing 8 questions (anxiety about the procedure, overall pain, back pain, difficulties in toiletting, walking, daily movement, selfcare and using the dominant hand) on a numeric rating scale (NRS, 0-10, 0 = none, 10 most severe). | 24 hours post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transradial access,