Misago® RX Self-expanding Peripheral Stent for Common and/or External Iliac Artery

Study Overview
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Brief Summary
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This is a multi-center, single arm, non-randomized, prospective clinical study using the Misago® RX Self-expanding Peripheral Stent for treatment of de novo, restenotic, and/or occlusive lesion(s) of the common and/or external iliac artery.

Official Title
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OSPREY ILIAC: Occlusive/Stenotic Peripheral Artery REvascularization StudY for Common and/or External ILIAC Artery Using the Misago® RX Self-expanding Peripheral Stent

Conditions
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Iliac Artery Stenosis

Intervention / Treatment
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* Device: Misago® RX Self-expanding Peripheral Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is ≥ 18 years old and of legal consent. Is willing to comply with all follow-up evaluations at the specified times. Subject or subject's legal representative has been informed of and understands the nature of the study and provides signed informed consent to participate in the study. Has a Rutherford Clinical Category Score of 2, 3 or 4. Radiographic evidence of ≥ 50% stenosis or restenosis (from PTA or adjunct therapy, not including stents or stent grafts), or occlusion of target lesion(s) in the common iliac artery and/or external iliac artery. Exclusion Criteria: Has had previous stent or stent-graft implantation in the target lesion(s). Has a contraindication or known untreatable allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs or any other drug used during the study according to the protocol. Has known hypersensitivity to contrast material that cannot be adequately pretreated. Has known hypersensitivity to nickel-titanium (nitinol).

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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Misago® RX Self-expanding Stent<br>Eligible participants will undergo stent implantation with the Misago® RX Self-expanding Stent | Device: Misago® RX Self-expanding Peripheral Stent<br>* the Misago® RX Self-expanding Stent is a bare metal, nitinol stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from the composite Major Adverse Event rate, defined as periprocedural related death, amputation of the target limb, and clinically driven TLR assessed at 9 months post-procedure. |  | 9 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Event rate at 30 days, and 12, 24, and 36 months post-procedure defined as a composite of peri-procedural related death, amputation of the target limb, and clinically driven TLR. |  | 30 days, 12, 24, and 36 months post-procedure | 
| Primary stent patency at 9 months defined by a binary duplex ultrasound peak systolic velocity ratio ≤ 2.4 at the stented target lesion and absence of TLR. |  | 9 months post-procedure | 
| Technical Success defined by the following conditions: 1) Successful delivery of the stent at the lesion site 2) Stent(s) successfully deployed in lesion with adequate lesion coverage | Technical success will be evaluated from time of enrollment through index procedure | The outcome is assessed up to 24 hours from time of enrollment through index procedure. | 
| Procedural Success: Attainment of < 30% residual stenosis of the target lesion and no peri-procedural complications. | Procedural success will be evaluated from time of enrollment through index procedure. Peri-procedural complications defined as: death, stroke, myocardial infarction (MI), emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel. | The outcome is assessed up to 24 hours from time of enrollment through index procedure | 
| Clinical Success: Relief or improvement (without increase of one or more in the score) from baseline symptoms as measured by the Rutherford score for chronic limb ischemia at 30 days as compared to baseline. | Clinical success will be evaluated from time of enrollment through index procedure. In addition, evaluation of Rutherford sustained (without increase of one or more in the score) at 9 months post-procedure from 30 days post-procedure for durability of results. | 30 days post-procedure | 
| Ankle Brachial Index (ABI) change from baseline |  | through 9 months post-procedure | 
| Clinically driven Target Vessel Revascularization (TVR) at 30 days and 9, 12, 24, and 36 months post-procedure | TVR is defined as any re-intervention or artery bypass surgery involving the target vessel in which the subject has ≥ 50% diameter stenosis with worsening symptoms, or ≥ 70% stenosis without symptoms. The target vessel is defined as the vessel containing the treated lesion (e.g., common and/or external iliac artery). | 30 days and 9, 12, 24, and 36 months post-procedure | 
| Clinically driven TLR through 30 days and 9, 12, 24, and 36 months post-procedure. | Clinically driven TLR is defined as re-intervention of the target lesion in which subject has ≥ 50% stenosis with worsening symptoms, or ≥ 70% stenosis without symptoms | 30 days and 9, 12, 24, and 36 months post-procedure | 
| Walking Impairment Questionnaire |  | change from baseline (pre-procedure) at 30 days and 9 months post procedure | 
| Evaluation of all AEs |  | pre-discharge through 36 months post-procedure | 
| Evaluation of access site complications including severe bleeding, hematoma, and pseudoaneurysm, occurring prior to hospital discharge. |  | The event is assessed from time of enrollment through hospital discharge or up to 7 days post procedure, whichever occurs first | 
| Occurrence of device deficiency | n there is inadequacy of a medical device with respect to its identity, quality, durability, reliability, usability, safety or performance. Device deficiencies include malfunctions, use errors, and inadequacy in the information supplied by the manufacturer including labelling | through 36 months post-procedure | 
| Device Related Complications |  | 9 months post-procedure |