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)

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.

Study Overview

• Status: Completed
• Conditions: Atherosclerotic Lesions in the Aortorenal Ostium
• Intervention / Treatment: Device: Express™ Renal Premounted Stent System

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital Care System
  • Illinois
    • Peoria, Illinois, United States, 61637
      • Peoria Radiology Associates Research & Education Foundation
    • Springfield, Illinois, United States, 62701
      • Prairie Education & Research Cooperative
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • The Care Group, Llc
    • Indianapolis, Indiana, United States, 46260
      • St. Vincent Hospital & Health Care Center, Inc.
  • Louisiana
    • Lafayette, Louisiana, United States, 70506
      • Cardiovascular Institute of the South (CIS)
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
  • New York
    • New York, New York, United States, 10032
      • NYPH & Trustees of Columbia University of New York
  • North Carolina
    • Raleigh, North Carolina, United States, 27610
      • WakeMed
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Philadelphia Health and Education Corp. d/b/a Drexel University College of Medicine
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Greenville Hospital System
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • North Central Heart Institute
  • Texas
    • Houston, Texas, United States, 77030
      • St. Luke's Episcopal Hospital
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • CAMC Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Change (improvement) in hypertension control from pre-procedure to post-procedure, 30-day and 9-month followups	9 Months
Major Adverse Events (MAEs): device- or index procedure related death ,TLR, Significant Embolic Event through 9 months post-procedure	9 Months
Technical success as visually assessed by the investigator.	Immediately after stent deployment

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (Actual): July 1, 2005
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: January 9, 2008
• First Submitted That Met QC Criteria: January 9, 2008
• First Posted (Estimate): January 17, 2008

Study Record Updates

• Last Update Posted (Estimate): November 21, 2014
• Last Update Submitted That Met QC Criteria: November 20, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: renal; atherosclerosis; stent; renal artery; renal stent; aortorenal ostium; PTRA
• Other Study ID Numbers: S2006