Atherosclerotic Lesions in the Aortorenal Ostium
Conditions
Keywords
renal stent, stent, atherosclerosis, aortorenal ostium, renal, renal artery, PTRA
Brief summary
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.
Interventions
DEVICEExpress™ Renal Premounted Stent System
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
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Binary in-stent restenosis rate of the Express™ Renal Stent at nine (9) months, defined by quantitative angiography. | 9 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Procedural Success - <30% residual diameter stenosis as visually assessed by the investigator without the occurrence of in-hospital MAE. | Post stent deployment |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed