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An Assessment of the Glider Balloon in Complex Lesions | Clinical Trials | Clareo Health

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An Assessment of the Glider Balloon in Complex Lesions

NCT02396186•TriReme Medical, LLC

Summary

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (4)

Alexian Brothers Heart and Vascualr Institute

Elk Grove Village, Illinois, United States

Washington University in St. Louis

St Louis, Missouri, United States

York Hospital

York, Pennsylvania, United States

Cardiovascular Specialists of Texas

Austin, Texas, United States

Key Dates

Start Date

March 1, 2015

Primary Completion Date

June 1, 2017

Completion Date

June 1, 2017

Last Updated

September 11, 2018

Enrollment

100

ACTUAL participants

Conditions

Coronary Artery Disease

Interventions

PTCA Balloon Angioplasty

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 11, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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An Assessment of the Glider Balloon in Complex Lesions

Inclusion Criteria

Exclusion Criteria

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