NCT01184352

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2010

Typical duration for all trials

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

December 6, 2012

Status Verified

December 1, 2012

Enrollment Period

2.2 years

First QC Date

August 16, 2010

Last Update Submit

December 5, 2012

Conditions

Coronary Disease

Outcome Measures

Primary Outcomes (1)

  • Technical Success

    Percentage of lesions successfully crossed among those attempted with the Glider PTCA Balloon Catheter as assesed during procedure.

    average of 1 hour

Secondary Outcomes (1)

  • Procedure Success

    average of 2 days

Study Arms (1)

PCI patients treated with Glider Device

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

Interventions

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

Percutaneous Coronary Interventions performed with the Glider PTCA Balloon Catheter

PCI patients treated with Glider Device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Vivantes Klinikum Zum Friedrichshain

Berlin, Germany

Location

Klinikum Coburg Herzkatheterlabor

Coburg, Germany

Location

Alfried Krupp Khs

Essen, Germany

Location

Elisabeth-Krankenhaus Essen Kardiologie

Essen, Germany

Location

University Klinikum Muenster

Münster, Germany

Location

Royal Brompton Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Carlo DiMario, MD

    Royal Brompton & Harefield NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2010

First Posted

August 18, 2010

Study Start

July 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

December 6, 2012

Record last verified: 2012-12

Locations

GB(1)DE(5)