Glider PTCA Balloon Catheter Registry

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.

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Key information

Conditions

Coronary Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vivantes Klinikum Zum Friedrichshain, Berlin, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TriReme Medical, Inc. Glider(TM) PTCA Balloon Catheter

Device

Percutaneous Coronary Interventions performed with the Glider PTCA Balloon Catheter

Primary outcomes

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.

Secondary outcomes

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).

Sponsors and collaborators

Lead sponsor

TriReme Medical, LLC

Industry

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Aug 18, 2010
Registry last updated: Dec 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed