Glider PTCA Balloon Catheter Registry

• Sponsor: TriReme Medical, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01184352
• Collaborator: (none)
• Enrollment: 125
• Locations: 6
• Duration (Months): 26.1
• Patients Per Site: 20.8
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Disease	Device: TriReme Medical, Inc. Glider(TM) PTCA Balloon Catheter

Study Design

• Study Type: Observational
• Actual Enrollment: 125 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Registry for PCI With the TriReme Medical, Inc. Glider(TM) PTCA Balloon Catheter
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vivantes Klinikum Zum Friedrichshain	Berlin		Germany
2	Klinikum Coburg Herzkatheterlabor	Coburg		Germany
3	Alfried Krupp Khs	Essen		Germany
4	Elisabeth-Krankenhaus Essen Kardiologie	Essen		Germany
5	University Klinikum Muenster	Muenster		Germany
6	Royal Brompton Hospital	London		United Kingdom

Sponsors and Collaborators

• TriReme Medical, LLC

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: TriReme Medical, LLC
• ClinicalTrials.gov Identifier: NCT01184352
• Other Study ID Numbers: CLR734
• First Posted: Aug 18, 2010
• Last Update Posted: Dec 6, 2012
• Last Verified: Dec 1, 2012

• Additional relevant MeSH terms: Coronary Disease

Study Results

No Results Posted as of Dec 6, 2012