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NCT02396186 Clinical Trial

An Assessment of the Glider Balloon in Complex Lesions

Coronary Artery Disease Clinical Trial

— ANTELOPE  

Official title:
An Assessment of the Glider Balloon in Complex Lesions

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02396186
Other study ID # CLP785
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2015
Est. completion date June 2017

Study information
Verified date September 2018
Source TriReme Medical, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• PTCA Balloon Angioplasty

Locations
Country Name City State
United States Cardiovascular Specialists of Texas Austin Texas
United States Alexian Brothers Heart and Vascualr Institute Elk Grove Village Illinois
United States Washington University in St. Louis Saint Louis Missouri
United States York Hospital York Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
TriReme Medical, LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Technical Success Rate Percentage of lesions successfully crossed among those attempted with the Glider PTCA catheter. 1 hour
Secondary Freedom from Balloon Slippage Percentage of inflations with the Glider balloon in which the physician user reports no slippage. 1 hour
Secondary Lesion Success Rate 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. 48 hours
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