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Vortex - Temporary Percutaneous, Transvalvular Circulatory Support System Feasibility Study

NCT04674111 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-04-24

Study results available
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Summary

Vortex - First in Human study to evaluate the feasibility, safety, clinical and technical success of the Vortex temporary percutaneous, transvalvular circulatory support system (Vortex System)

Conditions

Interventions

DEVICE

Temporary Percutaneous Transvalvular Circulatory Support System (Vortex System)

The Vortex System is intended to provide temporary circulatory support in subjects undergoing elective high-risk percutaneous coronary intervention (HR-PCI).

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Prof. Antony Walton, MBBS · The Alfred

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-28
Primary Completion
2022-04-08
Completion
2022-04-08

Countries

  • Australia
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

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 NCT04674111 on ClinicalTrials.gov