An Assessment of the Glider Balloon in Complex Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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PTCA Balloon Angioplasty

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No