An Assessment of the Glider Balloon in Complex Lesions

Status:	Completed
Conditions:	Peripheral Vascular Disease, Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	9/13/2018
Start Date:	March 2015
End Date:	June 2017

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.

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.

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

We found this trial at

sites

Cardiovascular Specialists of Texas

Austin, Texas 78758

Principal Investigator: Manish Chauhan, MD

Phone: 512-334-8973

from

Austin, TX