An Assessment of the Glider Balloon in Complex Lesions

Completed

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT02396186

Run by

TriReme Medical, LLC

People needed

100

Starts

2015-03-01

Expected to finish

2017-06-01

Last updated by the study team

2018-09-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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