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PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm

NCT06445608 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2025-06-13

No results posted yet for this study

Summary

This purpose of this trial is to demonstrate 30 day safety and effectiveness outcomes of the KARDION CORY P4 System in subjects who require hemodynamic support during a high-risk PCI procedure.

Conditions

Interventions

DEVICE

Percutaneous Mechanical Circulatory Support

Patients are randomized to receive one of two types of percutaneous mechanical circulatory support devices during a high-risk PCI procedure.

Sponsors & Collaborators

  • Kardion Inc

    lead INDUSTRY

Principal Investigators

  • Samin Sharma, MD · Icahn School of Medicine at Mount Sinai

  • William Nicholson, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-09-03
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States

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 NCT06445608 on ClinicalTrials.gov