Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
TriReme Medical, LLC
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | An Assessment of the Glider Balloon in Complex Lesions
