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Investigation of the Ringer Perfusion Balloon Catheter

NCT04849169 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-12-22

No results posted yet for this study

Summary

The objective of this study is to demonstrate reasonable assurance that the Ringer catheter can be safely used to manage hemorrhage due to coronary vessel perforations while facilitating distal perfusion under the conditions of use prescribed in the labeling.

Conditions

  • Coronary Artery Perforation

Interventions

DEVICE

Experimental

Prolonged balloon inflation for hemorrhage management due to coronary artery perforation.

Sponsors & Collaborators

  • Vascular Solutions LLC

    lead INDUSTRY

Principal Investigators

  • David E Kandzari, MD · Piedmont Heart Institute

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-18
Primary Completion
2023-11-21
Completion
2023-11-21
FDA Device
Yes

Countries

  • United States

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 NCT04849169 on ClinicalTrials.gov