Clareo Health | A Prospective, Multi-center, Single Arm Study Evaluating the Express™ Renal Premounted Stent System in the Treatment of Atherosclerotic Lesions in the Aortorenal Ostium.
A Prospective, Multi-center, Single Arm Study Evaluating the Express™ Renal Premounted Stent System in the Treatment of Atherosclerotic Lesions in the Aortorenal Ostium.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boston Scientific Corporation
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
Any previous or planned, surgery or percutaneous intervention ≤30 days prior to or after index procedure
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)
