An Assessment of the Glider Balloon in Complex Lesions

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02396186

Acronym

ANTELOPE

Enrollment

100

Registered

2015-03-24

Start date

2015-03-31

Completion date

2017-06-30

Last updated

2018-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

DEVICEPTCA Balloon Angioplasty

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026