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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: Recruiting NA study of Coronary Artery Disease, sponsored by Kardion.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary effectiveness endpoint of the clinical investigation is a composite endpoint of major adverse cardiac and cerebrovascular events (MACCE) comprised of all-cause death, myocardial infarction, stroke/TIA, target lesion revascularization, vascular complications, major bleeding, and acute kidney injury.
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
| Field | Value |
|---|---|
| Enrollment Target | 310 participants |
| Start Date | 2024-09-03 |
| Est. Completion | 2025-12 |
| Phase | NA |
What NCT06445608 shows while recruiting
NCT06445608 is an interventional study that assigns participants to a tested intervention. The registered 310 participants enrollment target is mid-sized for trials with a published cap, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (76% lower).
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 lists 18 locations in 15 states (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.
Learn More About Clinical Trials
Similar trials for Coronary Artery Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06445608's enrollment target sits among peer trials
310 101st of 219 higher than 119 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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