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

Phase 4

Completed

• Conditions: Atherosclerotic Lesions in the Aortorenal Ostium
• Interventions: Device: Express™ Renal Premounted Stent System

• Registration Number: NCT00597142
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2005-07
• Study First Submitted: 2008-01-09
• Study First Submitted QC: 2008-01-09
• Study First Posted: 2008-01-17
• Study Completion: 2009-10
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-20
• Last Update Posted: 2014-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Express™ Renal Premounted Stent System	-

Primary Outcome Measures

Name	Time	Method
Binary in-stent restenosis rate of the Express™ Renal Stent at nine (9) months, defined by quantitative angiography.	9 months

Secondary Outcome Measures

Name	Time	Method
Target Lesion Revascularization(TLR)*- Clinically driven reintervention of the target lesion through 9-months.	9 months
Change (improvement) in hypertension control from pre-procedure to post-procedure, 30-day and 9-month followups	9 Months
Technical success as visually assessed by the investigator.	Immediately after stent deployment
Procedural Success - <30% residual diameter stenosis as visually assessed by the investigator without the occurrence of in-hospital MAE.	Post stent deployment
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
Major Adverse Events (MAEs): device- or index procedure related death ,TLR, Significant Embolic Event through 9 months post-procedure	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

Trial Locations

Locations (14)

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

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