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NCT01184352 Clinical Trial

Glider PTCA Balloon Catheter Registry

Coronary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01184352
Other study ID # CLR734
Secondary ID
Status Completed
Phase N/A
First received August 16, 2010
Last updated December 5, 2012
Start date July 2010
Est. completion date September 2012

Study information
Verified date December 2012
Source TriReme Medical, LLC
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 125
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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:

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Device:
• TriReme Medical, Inc. Glider(TM) PTCA Balloon Catheter
Percutaneous Coronary Interventions performed with the Glider PTCA Balloon Catheter

Locations
Country Name City State
Germany Vivantes Klinikum Zum Friedrichshain Berlin
Germany Klinikum Coburg Herzkatheterlabor Coburg
Germany Alfried Krupp Khs Essen
Germany Elisabeth-Krankenhaus Essen Kardiologie Essen
Germany University Klinikum Muenster Muenster
United Kingdom Royal Brompton Hospital London

Sponsors (1)
Lead Sponsor Collaborator
TriReme Medical, LLC

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Technical Success Percentage of lesions successfully crossed among those attempted with the Glider PTCA Balloon Catheter as assesed during procedure. average of 1 hour No
Secondary Procedure Success 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 Yes
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