ClearWay™ RX Registry Trial

April 18, 2013 updated by: Atrium Medical Corporation

Multi-center, Registry Trial of ClearWay™ RX Local Therapeutic Infusion Catheter for All Indications

The primary goal of this registry is to collect data regarding the use of the ClearWay RX Local Therapeutic Infusion Catheter for all indications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The registry will collect de-identified data regarding the indication for use, ease of use, drug perfusion, catheterization procedure details, success for intended use, and overall operator performance evaluation.

Study Type

Observational

Enrollment (Actual)

102

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
    • California
      • Escondido, California, United States, 92025
        • Escondido Cardiology Associates
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
    • Florida
      • Winter Haven, Florida, United States, 33881
        • Winter Haven Florida
    • Georgia
      • Macon, Georgia, United States, 31202
        • The Georgia Heart Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Clarian Health Partners Methodist Research Institute
    • Kentucky
      • Paducah, Kentucky, United States, 42003
        • Western Baptist Hospital
    • Michigan
      • Grand Blanc, Michigan, United States, 48439
        • Genesys Regional Medical Center
      • St.Joseph, Michigan, United States, 49085
        • Great Lakes Heart & Vascular Institute
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • St.Mary's Duluth Clinic Health System
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Presbyterian Hospital Mid-Carolina Cardiology
      • Winston-Salem, North Carolina, United States, 27103
        • Forsyth Medical Center-Cardiovascular Research
    • Pennsylvania
      • Lebanon, Pennsylvania, United States, 17042
        • Good Samaritan Hospital
    • Virginia
      • Richmond, Virginia, United States, 23225
        • Virginia Cardiovascular Specialists

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The ClearWay Rx Registry enrolled subjects who required the use of the ClearWay Rx Local Therapeutic Infusion Catheter.

Description

Inclusion Criteria:

  • Subject required the use of the ClearWay Rx Local Therapeutic Infusion Catheter.

Exclusion Criteria:

  • Subject not meeting the above inclusion criterion

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ClearWay™ RX
Device: ClearWay™ RX Local Therapeutic Infusion Catheter
The ClearWay™ RX Local Therapeutic Infusion Catheter is a micro-porous PTFE balloon catheter designed for the localized infusion of various diagnostic and therapeutic agents into the coronary and peripheral vasculature.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
use, easy of use, drug perfusion, catheterization procedure details, success for intended use, and overall operator performance evaluation.
Time Frame: immediate
immediate

Collaborators and Investigators

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

Sponsor

Atrium Medical Corporation

Investigators

  • Principal Investigator: Ron Waksman, M.D., Medstar Health Research Institute

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

August 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

December 5, 2008

First Submitted That Met QC Criteria

December 5, 2008

First Posted (Estimate)

December 8, 2008

Study Record Updates

Last Update Posted (Estimate)

April 19, 2013

Last Update Submitted That Met QC Criteria

April 18, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20080711

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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