An Assessment of the Glider Balloon in Complex Lesions (ANTELOPE)

TriReme Medical

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: PTCA Balloon Angioplasty

Study type: Observational

Funder types: Industry

Identifiers

NCT02396186

CLP785

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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