Glider PTCA Balloon Catheter Registry

December 5, 2012 updated by: TriReme Medical, LLC

Registry for PCI With the TriReme Medical, Inc. Glider(TM) PTCA Balloon Catheter

The objective of this Registry is to demonstrate the utility of the Glider PTCA Balloon Catheter for crossing during the treatment of coronary artery disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

125

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

  • Germany
      • Berlin, Germany
        • Vivantes Klinikum Zum Friedrichshain
      • Coburg, Germany
        • Klinikum Coburg Herzkatheterlabor
      • Essen, Germany
        • Alfried Krupp Khs
      • Essen, Germany
        • Elisabeth-Krankenhaus Essen Kardiologie
      • Muenster, Germany
        • University Klinikum Muenster
  • United Kingdom
      • London, United Kingdom
        • Royal Brompton Hospital

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

Sampling Method

Probability Sample

Study Population

Patients treated by Physicians using the Glider PTCA Balloon Catheter who are willing to participate in the Glider Registry.

Description

Inclusion Criteria:

  • Patients undergoing PCI who are at least 18 years old
  • PCI procedure included the use of at least one Glider PTCA Balloon Catheter
  • Patient has been informed, in accordance with local requirements, that their data will be used in the Glider Registry

Exclusion Criteria:

  • N/A

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

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PCI patients treated with Glider Device
Device: TriReme Medical, Inc. Glider(TM) PTCA Balloon Catheter
Percutaneous Coronary Interventions performed with the Glider PTCA Balloon Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical Success
Time Frame: average of 1 hour
Percentage of lesions successfully crossed among those attempted with the Glider PTCA Balloon Catheter as assesed during procedure.
average of 1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure Success
Time Frame: average of 2 days
Percentage of patients treated with at least one Glider PTCA Balloon Catheter having <50% residual diameter stenosis, or TIMI 3 flow if at a bifurcation side branch, without the development of in-hospital MACE (Major Adverse Cardiac Event).
average of 2 days

Collaborators and Investigators

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

Sponsor

TriReme Medical, LLC

Investigators

  • Principal Investigator: Carlo DiMario, MD, Royal Brompton & Harefield NHS Foundation Trust

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

July 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

August 16, 2010

First Submitted That Met QC Criteria

August 17, 2010

First Posted (Estimate)

August 18, 2010

Study Record Updates

Last Update Posted (Estimate)

December 6, 2012

Last Update Submitted That Met QC Criteria

December 5, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLR734

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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