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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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
Sarasota Memorial Hospital Care System
Sarasota, Florida, United States
Peoria Radiology Associates Research & Education Foundation
Peoria, Illinois, United States
Binary in-stent restenosis rate of the Express™ Renal Stent at nine (9) months, defined by quantitative angiography.
Time frame: 9 months
Procedural Success - <30% residual diameter stenosis as visually assessed by the investigator without the occurrence of in-hospital MAE.
Time frame: Post stent deployment
Target Lesion Revascularization(TLR)*- Clinically driven reintervention of the target lesion through 9-months.
Time frame: 9 months
Target Vessel Revascularization(TVR)* - Clinically driven reintervention of the target vessel through 9-months.
Time frame: 9 Months
Change (improvement) in renal function from pre-procedure to post-procedure, 1-month and 9-month followups
Time frame: 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.
Time frame: 9 Months
Change (improvement) in hypertension control from pre-procedure to post-procedure, 30-day and 9-month followups
Time frame: 9 Months
Major Adverse Events (MAEs): device- or index procedure related death ,TLR, Significant Embolic Event through 9 months post-procedure
Time frame: 9 Months
Technical success as visually assessed by the investigator.
Time frame: Immediately after stent deployment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Prairie Education & Research Cooperative
Springfield, Illinois, United States
St. Vincent Hospital & Health Care Center, Inc.
Indianapolis, Indiana, United States
The Care Group, LLC
Indianapolis, Indiana, United States
Cardiovascular Institute of the South (CIS)
Lafayette, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
NYPH & Trustees of Columbia University of New York
New York, New York, United States
WakeMed
Raleigh, North Carolina, United States
Philadelphia Health and Education Corp. d/b/a Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
...and 4 more locations