An Assessment of the Glider Balloon in Complex Lesions

Status: Completed
Location: See all (4) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Illinois
Alexian Brothers Heart and Vascualr Institute
Elk Grove Village
Missouri
Washington University in St. Louis
Saint Louis
Pennsylvania
York Hospital
York
Texas
Cardiovascular Specialists of Texas
Austin
Time Frame
Start Date: 2015-03
Completion Date: 2017-06
Participants
Target number of participants: 100
Related Therapeutic Areas
Sponsors
Leads: TriReme Medical, LLC

This content was sourced from clinicaltrials.gov