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Clinical Trials/NCT02396186
NCT02396186CompletedNot Applicable

An Assessment of the Glider Balloon in Complex Lesions

TriReme Medical, LLC4 sites in 1 country100 target enrollmentStarted: March 2015Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
4
Primary Endpoint
Technical Success Rate
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Technical Success Rate

Time Frame: 1 hour

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

Secondary Outcomes

  • Freedom from Balloon Slippage(1 hour)
  • Lesion Success Rate(48 hours)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (4)

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An Assessment of the Glider Balloon in... | Clinical Trial