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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 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.

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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).

Conditions Studied

Coronary Artery Disease Angina, Stable NSTEMI - Non-ST Segment Elevation MI Unstable Angina

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

FieldValue
Enrollment Target 406 participants
Start Date 2019-09-01
Est. Completion 2021-09-30

Sponsor

Abiomed

20 total trials

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What the Registry Record Tells You About NCT04648306

The ClinicalTrials.gov registry entry for NCT04648306 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 406 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,285-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (68% lower). The listed sponsor is Abiomed, which has 20 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.