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

NCT00597142 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2014-11-21

No results posted yet for this study

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.

Conditions

  • Atherosclerotic Lesions in the Aortorenal Ostium

Interventions

DEVICE

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

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Pamela Grady, PhD · Boston Scientific Corporation

  • Krishna Rocha-Singh, MD · Prairie Cardiovascular Heart Institute, St. John's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2005-07-31
Completion
2009-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00597142 on ClinicalTrials.gov