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NCT04648306 · ClinicalTrials.gov registry record
Restore EF Observational Study
A clinical trial of Coronary Artery Disease and Angina, Stable, sponsored by Abiomed.
- Completed
- Registry status
- 406
- Enrollment target
- 20
- Study locations
NCT04648306: Completed study of Coronary Artery Disease and Angina, Stable, sponsored by Abiomed.
NCT04648306 is a study of Coronary Artery Disease and Angina, Stable that has completed, run by Abiomed. The registered enrollment target is 406 participants, below the 1,285-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04648306, a study of Coronary Artery Disease and Angina, Stable, has completed, sponsored by Abiomed.
- COMPLETED
- Registry status
- 406 participants
- Enrollment target
- 20
- Study locations
Study Summary
A multi-center, prospective, observational, non-interventional single arm, study of the intermediate-term clinical outcomes collected from electronic health records of high-risk patients which have previously undergone standard of care prophylactic Impella support for a non-emergent percutaneous coronary intervention (PCI).
Primary Outcome
Left ventricular ejection fraction (LVEF) %
Conditions Studied
Interventions
- DEVICE Prophylactic Impella support for a non-emergent PCI
Study Locations (20)
Arkansas
- Washington Regional Medical Center - Fayetteville
- Arkansas Cardiology P.A. - North Little Rock
- Northwest Medical Center - Springdale
Arizona
- St. Joseph's Medical Center - Phoenix
- Tucson Medical Center - Tucson
California
- Loma Linda University Medical - Loma Linda
- UCSD Medical Center - San Diego
Minnesota
- Mercy Hospital - Coon Rapids
- St. Cloud Hospital - Saint Cloud
Texas
- Presbyterian Hospital Dallas - Arlington
- Kingwood Medical Center - Kingwood
Florida
- Advent Health - Daytona Beach
Illinois
- NorthShore University HealthSystem - Skokie
Iowa
- Genesis Medical Center - Davenport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 406 participants |
| Start Date | 2019-09-01 |
| Est. Completion | 2021-09-30 |
What the finished NCT04648306 record still lists
NCT04648306 is an observational study that tracks outcomes without assigning an intervention. The registered 406 participants enrollment target is mid-sized for trials with a published cap, below the 1,285-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (68% lower).
The record links to 4 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 1 intervention - of which Prophylactic Impella support for a non-emergent PCI is the first listed.
NCT04648306 names 20 study sites across 14 states, led by Arkansas, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT04648306 about?
NCT04648306 is a clinical study titled "Restore EF Observational Study". A multi-center, prospective, observational, non-interventional single arm, study of the intermediate-term clinical outcomes collected from electronic health records of high-risk patients which have previously undergone standard of care prophylactic Impella support for a non-emergent percutaneous cor...
What is the current status of trial NCT04648306?
This trial is currently completed. The enrollment target is 406 participants. The study started on 2019-09-01. Estimated completion is 2021-09-30.
What conditions does trial NCT04648306 study?
This clinical trial studies the following conditions: Coronary Artery Disease, Angina, Stable, NSTEMI - Non-ST Segment Elevation MI, Unstable Angina.
What interventions are being tested in trial NCT04648306?
The interventions under investigation include: Prophylactic Impella support for a non-emergent PCI (DEVICE).
Who is sponsoring clinical trial NCT04648306?
This trial is sponsored by Abiomed, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04648306 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04648306's enrollment target sits among peer trials
406 87th of 219 higher than 133 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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