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OpenTrials
Completed

NCT Number: NCT02396186

An Assessment of the Glider Balloon in Complex Lesions

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Lesion must be successfully crossed with a guidewire without complication (including Chronic Total Occlusions (CTOs))
  • The Glider balloon may only be used at one lesion during the procedure
  • The lesion in which the Glider balloon is used must be completed first
  • The primary lesion treated during the procedure must be treated with the Glider balloon
  • 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

  • Patient < 18 years of age
  • Lesion longer than 40mm
  • Device use not consistent with Instructions for Use
  • Patient has not given consent for their data to be submitted to this registry

Treatment and study plan

PTCA Balloon Angioplasty

Device

Primary outcomes

  1. Technical Success Rate

    Time frame: 1 hour

    Percentage of lesions successfully crossed among those attempted with the Glider PTCA catheter.

Secondary outcomes

  1. Freedom from Balloon Slippage

    Time frame: 1 hour

    Percentage of inflations with the Glider balloon in which the physician user reports no slippage.

  2. Lesion Success Rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

TriReme Medical, LLC

Industry

Registry information

Acronym: ANTELOPE

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 24, 2015
Registry last updated
Sep 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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