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Investigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA)

NCT04862689 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-12-22

No results posted yet for this study

Summary

The objective of this study is to demonstrate safe and effective use of the Ringer perfusion balloon catheter for dilatation/pre-dilatation of coronary stenoses during percutaneous coronary intervention (PCI).

Conditions

  • Coronary Stenosis

Interventions

DEVICE

Ringer Perfusion Balloon Catheter

Non-emergent Percutaneous Coronary Intervention (PCI) for treatment of a coronary artery lesion with Ringer Perfusion Balloon Catheter.

Sponsors & Collaborators

  • Vascular Solutions LLC

    lead INDUSTRY

Principal Investigators

  • Sherry Lane · Teleflex

  • Kathleen Kearney, MD · University of Washington

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2023-06-30
Completion
2023-06-30
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04862689 on ClinicalTrials.gov