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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 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.

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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

Coronary Artery Disease Left Ventricular Dysfunction

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

FieldValue
Enrollment Target 1,252 participants
Start Date 2021-04-13
Est. Completion 2027-10
Phase NA

Sponsor

Abiomed

20 total trials

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What the Registry Record Tells You About NCT04763200

The ClinicalTrials.gov registry entry for NCT04763200 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 1,252 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 1,281-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target. The listed sponsor is Abiomed, which has 20 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.

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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.