An Assessment of the Glider Balloon in Complex Lesions (ANTELOPE)

September 7, 2018 updated by: TriReme Medical, LLC
The purpose of this study is to collect data from real-world use with the Glider Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter to support the effectiveness of the Glider PTCA Balloon for crossing into complex coronary lesions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Observational Study collecting data on commercial cases in which the Glider PTCA Balloon Catheter is used in accordance with the instructions for use. This study includes up 500 patients at up to 50 study sites.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • Alexian Brothers Heart and Vascualr Institute
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University in St. Louis
    • Pennsylvania
      • York, Pennsylvania, United States, 17403
        • York Hospital
    • Texas
      • Austin, Texas, United States, 78758
        • Cardiovascular Specialists of Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All cases of coronary interventions involving the Glider™ PTCA Balloon Catheter at participating centers will be reviewed for patient eligibility. Patients from all eligible cases should be invited to sign an IRB-approved Informed Consent.

Description

Inclusion Criteria:

  1. Lesion must be successfully crossed with a guidewire without complication (including Chronic Total Occlusions (CTOs))
  2. The Glider balloon may only be used at one lesion during the procedure
  3. The lesion in which the Glider balloon is used must be completed first
  4. The primary lesion treated during the procedure must be treated with the Glider balloon

  5. Intended treatment of a protocol-defined complex lesion that has at least one of the following factors:

    • Significant vessel tortuosity
    • Failed balloon crossing with another balloon
    • Tight stenosis
    • Heavy calcification
    • Side branch present

Exclusion Criteria:

  1. Patient < 18 years of age
  2. Lesion longer than 40mm
  3. Device use not consistent with Instructions for Use
  4. Patient has not given consent for their data to be submitted to this registry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical Success Rate
Time Frame: 1 hour
Percentage of lesions successfully crossed among those attempted with the Glider PTCA catheter.
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from Balloon Slippage
Time Frame: 1 hour
Percentage of inflations with the Glider balloon in which the physician user reports no slippage.
1 hour
Lesion Success Rate
Time Frame: 48 hours
Percentage of lesions with <50% diameter stenosis, or Thrombolysis In Myocardial Infarction (TIMI) 3 flow if side branch is present, without development of MACE during hospital stay.
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TriReme Medical, LLC

Investigators

  • Principal Investigator: David Rizik, MD, Scottsdale Healthcare
  • Principal Investigator: William Lombardi, MD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

March 18, 2015

First Submitted That Met QC Criteria

March 23, 2015

First Posted (Estimate)

March 24, 2015

Study Record Updates

Last Update Posted (Actual)

September 11, 2018

Last Update Submitted That Met QC Criteria

September 7, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLP785

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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