NCT00597142|CompletedPhase 4DMC
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
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Sponsor study identifier
interventional
100
1 country
14
Study Start
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2005
Actual (reported)Study Completion
October 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
July 2005
Actual (reported)January 9, 2008
Actual (reported)January 17, 2008
Actual (reported)October 2009
Actual (reported)Binary in-stent restenosis rate of the Express™ Renal Stent at nine (9) months, defined by quantitative angiography.
9 months
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
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Sarasota Memorial Hospital Care System
Sarasota, Florida, 34239, United States
Peoria Radiology Associates Research & Education Foundation
Peoria, Illinois, 61637, United States
Prairie Education & Research Cooperative
Springfield, Illinois, 62701, United States
St. Vincent Hospital & Health Care Center, Inc.
Indianapolis, Indiana, 46260, United States
The Care Group, LLC
Indianapolis, Indiana, 46260, United States
Cardiovascular Institute of the South (CIS)
Lafayette, Louisiana, 70506, United States
Ochsner Clinic Foundation
Rocha-Singh K, Jaff MR, Lynne Kelley E; RENAISSANCE Trial Investigators. Renal artery stenting with noninvasive duplex ultrasound follow-up: 3-year results from the RENAISSANCE renal stent trial. Catheter Cardiovasc Interv. 2008 Nov 15;72(6):853-62. doi: 10.1002/ccd.21749.
Pamela Grady, PhD
Boston Scientific Corporation
Krishna Rocha-Singh, MD
Prairie Cardiovascular Heart Institute, St. John's Hospital
100 participants (actual enrollment reported by the registry).
First Submitted
January 9, 2008
First Posted
January 17, 2008
Study Start
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
New Orleans, Louisiana, 70121, United States
NYPH & Trustees of Columbia University of New York
New York, New York, 10032, United States
WakeMed
Raleigh, North Carolina, 27610, United States
Philadelphia Health and Education Corp. d/b/a Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102, United States
Greenville Hospital System
Greenville, South Carolina, 29605, United States
North Central Heart Institute
Sioux Falls, South Dakota, 57108, United States
St. Luke's Episcopal Hospital
Houston, Texas, 77030, United States
CAMC Institute
Charleston, West Virginia, 25304, United States
Primary Completion
July 2005
Actual (reported)Study Completion
October 2009
Actual (reported)Last Updated
November 21, 2014
Record last verified: 2014-11
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Source: ClinicalTrials.gov.
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