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NCT04763200 · ClinicalTrials.gov registry record · NA
Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function
A NA study of Coronary Artery Disease and Left Ventricular Dysfunction, sponsored by Abiomed.
- Active
- Registry status
- NA
- Development phase
- 1,252
- Enrollment target
- 20
- Study locations
NCT04763200: Active NA study of Coronary Artery Disease and Left Ventricular Dysfunction, sponsored by Abiomed.
NCT04763200 is a NA study of Coronary Artery Disease and Left Ventricular Dysfunction that is active but no longer recruiting, run by Abiomed. The registered enrollment target is 1,252 participants, roughly in line with the 1,281-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target. The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04763200, a NA study of Coronary Artery Disease and Left Ventricular Dysfunction, is active but no longer recruiting, sponsored by Abiomed.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 1,252 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health after a heart procedure compared to the current standard of care.
Conditions Studied
Interventions
- DEVICE Impella CP® / Impella CP® with SmartAssist® / Impella 2.5®
- DEVICE IABP Intra-aortic balloon pump
Study Locations (20)
California
- Adventist Health Glendale - Glendale
- St. Joseph Hospital - Orange - Orange
- Loma Linda University Health - San Bernardino
- UCSD Medical Center - San Diego
Illinois
- Rush University Medical Center - Chicago
- NorthShore University Health System - Evanston
- Northwestern University - Evanston
- Advocate Christ Medical Center - Oak Lawn
Florida
- The Cardiac & Vascular Institute - Gainesville
- University of Florida Health - Gainesville - Gainesville
- UF Health Jacksonville - Jacksonville
Arizona
- St. Joseph's Medical Center - Phoenix - Phoenix
- Northwest Medical Center Tucson - Tucson
Georgia
- Emory University Hospital - Atlanta
- Northside Cardiovascular Institute - Lawrenceville
Alabama
- University of Alabama - Birmingham
Arkansas
- Arkansas Cardiology - Little Rock
Colorado
- Colorado Heart and Vascular - Lakewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,252 participants |
| Start Date | 2021-04-13 |
| Est. Completion | 2027-10 |
| Phase | NA |
What the registry record for NCT04763200 still lists
NCT04763200 is an interventional study that assigns participants to a tested intervention. Its 1,252 participants enrollment target places it among the larger protocols in the corpus, roughly in line with the 1,281-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target.
The record links to 2 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which Impella CP® / Impella CP® with SmartAssist® / Impella 2.5® is the first listed.
NCT04763200 names 20 study sites across 10 states, led by California, Illinois, Florida.
Frequently Asked Questions
What is clinical trial NCT04763200 about?
NCT04763200 is a clinical study titled "Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function". The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health after a heart procedure compared to the current standard of care.
What is the current status of trial NCT04763200?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 1,252 participants. The study started on 2021-04-13. Estimated completion is 2027-10.
What conditions does trial NCT04763200 study?
This clinical trial studies the following conditions: Coronary Artery Disease, Left Ventricular Dysfunction.
What interventions are being tested in trial NCT04763200?
The interventions under investigation include: Impella CP® / Impella CP® with SmartAssist® / Impella 2.5® (DEVICE), IABP Intra-aortic balloon pump (DEVICE).
Who is sponsoring clinical trial NCT04763200?
This trial is sponsored by Abiomed, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04763200 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04763200's enrollment target sits among peer trials
1,252 41st of 219 higher than 179 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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