REFORM Clinical Study: Treatment of Renal Artery Stenosis With the Formula Balloon-Expandable Stent

November 21, 2013 updated by: Cook Group Incorporated
The purpose of the study is to evaluate the safety and effectiveness of the Formula Balloon-Expandable Stent in treatment of renal artery stenosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Ocala, Florida, United States, 34471
        • Munroe Regional Medical Center
      • Orlando, Florida, United States, 32806
        • Orlando Regional Medical Center
    • New York
      • New York, New York, United States, 10075
        • Lenox Hill Hospital
    • North Carolina
      • Raleigh, North Carolina, United States, 27610
        • Wake Med Raleigh Campus
    • Ohio
      • Lancaster, Ohio, United States, 43130
        • Fairfield Medical Center
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17110
        • Pinnacle Health at Harrisburg
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • renal artery stenosis
  • appropriate size and location of the lesion
  • suboptimal angioplasty

Key Exclusion Criteria:

  • less than 18 years old
  • failure or inability to give informed consent
  • simultaneously participating in another drug or device study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
renal artery stenting
Device: Formula Balloon-Expandable Stent
renal artery stenting
Other Names:
  • renal artery revascularization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Patency of the Treated Renal Artery
Time Frame: 9 Months
Based on ultrasound images assessed by core lab.
9 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With 30-day Major Adverse Events
Time Frame: 30 Days
Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events.
30 Days
Number of Participants With 9-month Major Adverse Events
Time Frame: 9 Months
Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events.
9 Months
Technical Success
Time Frame: Prior to Discharge
Successful delivery and deployment of a Formula™ Balloon-Expandable Stent at index procedure.
Prior to Discharge
Acute Procedural Success
Time Frame: Prior to Discharge
< 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events before discharge.
Prior to Discharge
30-day Clinical Success
Time Frame: 30 Days
< 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events within 30 days.
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Group Incorporated

Investigators

  • Principal Investigator: Robert Bersin, MD, Swedish Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

February 28, 2008

First Submitted That Met QC Criteria

March 6, 2008

First Posted (Estimate)

March 7, 2008

Study Record Updates

Last Update Posted (Estimate)

December 16, 2013

Last Update Submitted That Met QC Criteria

November 21, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-581
  • FRUS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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