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RECRUITING NA

PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm

NCT06445608 · View on ClinicalTrials.gov ↗

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06445608

The ClinicalTrials.gov registry entry for NCT06445608 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 310 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kardion, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06445608 reports 18 study locations spanning 15 distinct geographic areas — top geographies include Arizona, New York, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06445608?

The interventions under investigation include: Percutaneous Mechanical Circulatory Support (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06445608?

This trial is sponsored by Kardion, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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