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)

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00597142
First received: January 9, 2008
Last updated: January 10, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Atherosclerotic Lesions in the Aortorenal Ostium
Device: Express™ Renal Premounted Stent System
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center, Single Arm Study Evaluating the Express™ Renal Premounted Stent System in the Treatment of Atherosclerotic Lesions in the Aortorenal Ostium.

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Binary in-stent restenosis rate of the Express™ Renal Stent at nine (9) months, defined by quantitative angiography. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Procedural Success - <30% residual diameter stenosis as visually assessed by the investigator without the occurrence of in-hospital MAE. [ Time Frame: Post stent deployment ] [ Designated as safety issue: Yes ]
  • Target Lesion Revascularization(TLR)*- Clinically driven reintervention of the target lesion through 9-months. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Target Vessel Revascularization(TVR)* - Clinically driven reintervention of the target vessel through 9-months. [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
  • Change (improvement) in renal function from pre-procedure to post-procedure, 1-month and 9-month followups [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Change (improvement) in hypertension control from pre-procedure to post-procedure, 30-day and 9-month followups [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
  • Major Adverse Events (MAEs): device- or index procedure related death ,TLR, Significant Embolic Event through 9 months post-procedure [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
  • Technical success as visually assessed by the investigator. [ Time Frame: Immediately after stent deployment ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: January 2004
Study Completion Date: October 2009
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597142

Locations
United States, Florida
Sarasota Memorial Hospital Care System
Sarasota, Florida, United States, 34239
United States, Illinois
Peoria Radiology Associates Research & Education Foundation
Peoria, Illinois, United States, 61637
Prairie Education & Research Cooperative
Springfield, Illinois, United States, 62701
United States, Indiana
The Care Group, LLC
Indianapolis, Indiana, United States, 46260
St. Vincent Hospital & Health Care Center, Inc.
Indianapolis, Indiana, United States, 46260
United States, Louisiana
Cardiovascular Institute of the South (CIS)
Lafayette, Louisiana, United States, 70506
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, New York
NYPH & Trustees of Columbia University of New York
New York, New York, United States, 10032
United States, North Carolina
WakeMed
Raleigh, North Carolina, United States, 27610
United States, Pennsylvania
Philadelphia Health and Education Corp. d/b/a Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102
United States, South Carolina
Greenville Hospital System
Greenville, South Carolina, United States, 29605
United States, South Dakota
North Central Heart Institute
Sioux Falls, South Dakota, United States, 57108
United States, Texas
St. Luke's Episcopal Hospital
Houston, Texas, United States, 77030
United States, West Virginia
CAMC Institute
Charleston, West Virginia, United States, 25304
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Study Director: Pamela Grady, PhD Boston Scientific Corporation
Principal Investigator: Krishna Rocha-Singh, MD Prairie Cardiovascular Heart Institute, St. John's Hospital
  More Information

Publications:
Responsible Party: Colleen Holthe, Boston Scientific
ClinicalTrials.gov Identifier: NCT00597142     History of Changes
Other Study ID Numbers: S2006
Study First Received: January 9, 2008
Last Updated: January 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:
renal stent
stent
atherosclerosis
aortorenal ostium
renal
renal artery
PTRA

ClinicalTrials.gov processed this record on October 19, 2014