A Prospective, Multi-center, Single Arm Study Evaluating the Express™ Renal Premounted Stent System in the Treatment of Atherosclerotic Lesions in the Aortorenal Ostium.
NCT ID: NCT00597142
Last Updated: 2014-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2004-01-31
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Express™ 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
Interventions
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Express™ 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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Pamela Grady, PhD
Role: STUDY_DIRECTOR
Boston Scientific Corporation
Krishna Rocha-Singh, MD
Role: PRINCIPAL_INVESTIGATOR
Prairie Cardiovascular Heart Institute, St. John's Hospital
Locations
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Sarasota Memorial Hospital Care System
Sarasota, Florida, United States
Peoria Radiology Associates Research & Education Foundation
Peoria, Illinois, United States
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
Greenville Hospital System
Greenville, South Carolina, United States
North Central Heart Institute
Sioux Falls, South Dakota, United States
St. Luke's Episcopal Hospital
Houston, Texas, United States
CAMC Institute
Charleston, West Virginia, United States
Countries
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References
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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.
Other Identifiers
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S2006
Identifier Type: -
Identifier Source: org_study_id