A Prospective, Multi-center, Single Arm Study Evaluating the Express™ Renal Premounted Stent System in the Treatment of Atherosclerotic Lesions in the Aortorenal Ostium.

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate superior 9-month binary restenosis rate of the Express™ Renal Premounted Stent System as compared to an Objective Performance Criterion representative of PTRA, for atherosclerotic lesions in the aortorenal ostium.

Official Title
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A Prospective, Multi-center, Single Arm Study Evaluating the Express™ Renal Premounted Stent System in the Treatment of Atherosclerotic Lesions in the Aortorenal Ostium.

Conditions
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Atherosclerotic Lesions in the Aortorenal Ostium

Intervention / Treatment
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* Device: Express™ Renal Premounted Stent System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible for PTRA and stenting. One or more of the following: (1-3) Hypertension Recurrent flash pulmonary edema out of proportion to any impairment of left ventricular function Renal Dysfunction Single, de novo, or restenotic (from prior PTRA) atherosclerotic lesion in the ostium of the renal artery Lesion involving the aortorenal ostium or the leading edge of the stenosis is located within 5 mm of the opacified aortic lumen Renal Artery Stenosis: bilateral renal artery stenosis (one stent for one lesion in each renal artery) or unilateral renal artery stenosis, including a solitary functioning kidney Exclusion Criteria: Any previous or planned, surgery or percutaneous intervention ≤30 days prior to or after index procedure Advanced renal disease: serum creatinine > 3.0 mg/dl End stage renal disease requiring dialysis; or previously diagnosed ephrosclerosis Recent vascular event ≤30 days pre-procedure (i.e. acute coronary syndrome, decompensated heart failure, transient ischemic attack or stroke.) Documented allergy or reaction to iodinated contrast media, including laryngeal edema, convulsions, profound hypotension,unresponsiveness, cardiopulmonary arrest, and clinically manifest arrhythmias (a mild allergy to contrast media that can be pretreated with medication is acceptable) Documented allergy to heparin, acetylsalicylic acid (ASA) or clopidogrel NYHA Class IV Bleeding diathesis Thrombocytopenia (platelets < 100,000/mm3) Renal atrophy (renal length ≤ 8 cm determined by renal ultrasound) Patients requiring immunosuppressive therapy Renal allograft Stenosis location in a vascular graft or in a transplant artery Angiographic Exclusion Total occlusions Thrombus containing lesion Prior treatment of target lesion with stent (in-stent restenosis) More than one (1) lesion in target vessel Non-atherosclerotic stenosis (fibromuscular dysplasia) Excessive vessel tortuosity Lesion involving a side-branch Lesion in accessory renal artery Abdominal aortic aneurysm > 3.5 cm Perforated vessels evidenced by extravasation of contrast media

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: 1<br> | Device: Express™ Renal Premounted Stent System<br>* This device is indicated for use as an adjunct to percutaneous transluminal renal angioplasty (PTRA) of a: Single, de novo or restenotic (from PTRA) atherosclerotic lesion in the ostium of the renal artery Lesion length ≤15mm Lesion involving the aortorenal ostium or the leading edge of the stenosis is located within 5 mm of the opacified aortic lumen RVD 4.0-7.0mm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binary in-stent restenosis rate of the Express™ Renal Stent at nine (9) months, defined by quantitative angiography. |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Success - <30% residual diameter stenosis as visually assessed by the investigator without the occurrence of in-hospital MAE. |  | Post stent deployment | 
| Target Lesion Revascularization(TLR)*- Clinically driven reintervention of the target lesion through 9-months. |  | 9 months | 
| Target Vessel Revascularization(TVR)* - Clinically driven reintervention of the target vessel through 9-months. |  | 9 Months | 
| Change (improvement) in renal function from pre-procedure to post-procedure, 1-month and 9-month followups |  | 9 months | 
| Change in Renal to Aortic Ratio, Resistive Index, and Peak Systolic Velocity using Ultrasound Core Lab values from pre-procedure to postprocedure and 9-months post-procedure. |  | 9 Months | 
| Change (improvement) in hypertension control from pre-procedure to post-procedure, 30-day and 9-month followups |  | 9 Months | 
| Major Adverse Events (MAEs): device- or index procedure related death ,TLR, Significant Embolic Event through 9 months post-procedure |  | 9 Months | 
| Technical success as visually assessed by the investigator. |  | Immediately after stent deployment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal stent, stent, atherosclerosis, aortorenal ostium, renal, renal artery, PTRA