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

Boston Scientific

Status and phase

Completed

Phase 4

Conditions

Atherosclerotic Lesions in the Aortorenal Ostium

Treatments

Device: Express™ Renal Premounted Stent System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00597142

S2006

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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