Glider PTCA Balloon Catheter Registry

Completed

• Conditions: Coronary Disease
• Interventions: Device: TriReme Medical, Inc. Glider(TM) PTCA Balloon Catheter

• Registration Number: NCT01184352
• Lead Sponsor: TriReme Medical, LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-08-16
• Study First Submitted QC: 2010-08-17
• Study First Posted: 2010-08-18
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-05
• Last Update Posted: 2012-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PCI patients treated with Glider Device	TriReme Medical, Inc. Glider(TM) PTCA Balloon Catheter	-

Primary Outcome Measures

Name	Time	Method
Technical Success	average of 1 hour	Percentage of lesions successfully crossed among those attempted with the Glider PTCA Balloon Catheter as assesed during procedure.

Secondary Outcome Measures

Name	Time	Method
Procedure Success	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).

Trial Locations

Locations (6)

Elisabeth-Krankenhaus Essen Kardiologie; 🇩🇪 Essen, Germany

Vivantes Klinikum Zum Friedrichshain; 🇩🇪 Berlin, Germany

Alfried Krupp Khs; 🇩🇪 Essen, Germany

Klinikum Coburg Herzkatheterlabor; 🇩🇪 Coburg, Germany

University Klinikum Muenster; 🇩🇪 Muenster, Germany

Royal Brompton Hospital; 🇬🇧 London, United Kingdom