An Assessment of the Glider Balloon in Complex Lesions

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT02396186
• Lead Sponsor: TriReme Medical, LLC

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-18
• Study First Submitted QC: 2015-03-23
• Study First Posted: 2015-03-24
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-07
• Last Update Posted: 2018-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Technical Success Rate	1 hour	Percentage of lesions successfully crossed among those attempted with the Glider PTCA catheter.

Secondary Outcome Measures

Name	Time	Method
Freedom from Balloon Slippage	1 hour	Percentage of inflations with the Glider balloon in which the physician user reports no slippage.
Lesion Success Rate	48 hours	Percentage of lesions with \<50% diameter stenosis, or Thrombolysis In Myocardial Infarction (TIMI) 3 flow if side branch is present, without development of MACE during hospital stay.

Trial Locations

Locations (4)

Alexian Brothers Heart and Vascualr Institute; 🇺🇸 Elk Grove Village, Illinois, United States

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States

Cardiovascular Specialists of Texas; 🇺🇸 Austin, Texas, United States

York Hospital; 🇺🇸 York, Pennsylvania, United States