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NCT06445608 · ClinicalTrials.gov registry record · NA

PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm

A NA study of Coronary Artery Disease, sponsored by Kardion.

Recruiting
Registry status
NA
Development phase
310
Enrollment target
18
Study locations

NCT06445608 is a NA study of Coronary Artery Disease that is actively recruiting participants, run by Kardion. The registered enrollment target is 310 participants, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (76% lower). The trial reports 18 study locations across 15 states.

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The verdict

NCT06445608, a NA study of Coronary Artery Disease, is actively recruiting participants, sponsored by Kardion.

RECRUITING
Registry status
NA
Development phase
310 participants
Enrollment target
18
Study locations

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 Studied

Interventions

  • DEVICE Percutaneous Mechanical Circulatory Support

Study Locations (18)

Arizona

  • Dignity Health - Chandler Regional Medical Center - Chandler
  • HonorHealth Research and Innovation Institute - Scottsdale

New York

  • Mount Sinai - New York
  • St. Francis Hospital - Roslyn

Ohio

  • The Lindner Research Center at The Christ Hospital - Cincinnati
  • Ohio Health Research Institute - Columbus

Arkansas

  • Arkansas Cardiology, P.A. - Little Rock

Colorado

  • North Suburban Medical Center - Thornton

Connecticut

  • Hartford Hospital - Hartford

Florida

  • Ascension St. Vincent's - Jacksonville

Georgia

  • Emory University - Atlanta

Trial Details

FieldValue
Enrollment Target 310 participants
Start Date 2024-09-03
Est. Completion 2025-12
Phase NA

Sponsor

Kardion

1 total trials

What the Registry Record Tells You About NCT06445608

The ClinicalTrials.gov registry entry for NCT06445608 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 310 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (76% lower). The listed sponsor is Kardion, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 1 intervention - of which Percutaneous Mechanical Circulatory Support is the first listed.

NCT06445608 reports 18 study locations spanning 15 distinct geographic areas - top geographies include Arizona, New York, Ohio.

Frequently Asked Questions

What is clinical trial NCT06445608 about?

NCT06445608 is a clinical study titled "PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm". 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.

What is the current status of trial NCT06445608?

This trial is currently recruiting. It is a NA study. The enrollment target is 310 participants. The study started on 2024-09-03. Estimated completion is 2025-12.

What conditions does trial NCT06445608 study?

This clinical trial studies the following conditions: Coronary Artery Disease.

What interventions are being tested in trial NCT06445608?

The interventions under investigation include: Percutaneous Mechanical Circulatory Support (DEVICE).

Who is sponsoring clinical trial NCT06445608?

This trial is sponsored by Kardion, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06445608 being conducted?

This trial has 18 study locations across Arizona, Arkansas, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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