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Mechanical Circulatory Support Device

Impella cohort for Coronary Artery Disease

N/A
Waitlist Available
Research Sponsored by Abiomed Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days post protected pci (60 to 180 days window)
Awards & highlights

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).

Eligible Conditions
  • Coronary Artery Disease
  • Stable Angina
  • Angina
  • Myocardial Infarction

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days post protected pci (60 to 180 days window)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days post protected pci (60 to 180 days window) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Left ventricular ejection fraction (LVEF)
Secondary study objectives
NYHA Functional Class
Readmission
Survival Rate

Trial Design

1Treatment groups
Experimental Treatment
Group I: Impella cohortExperimental Treatment1 Intervention
Single arm study of patients who underwent non-emergent percutaneous coronary intervention with prophylactic Impella support
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prophylactic Impella support for a non-emergent PCI
2019
N/A
~410

Find a Location

Who is running the clinical trial?

Abiomed Inc.Lead Sponsor
41 Previous Clinical Trials
32,613 Total Patients Enrolled
3 Trials studying Coronary Artery Disease
1,714 Patients Enrolled for Coronary Artery Disease
Craig Thompson, MDStudy ChairNYU Langone
1 Previous Clinical Trials
80 Total Patients Enrolled
Jason Wollmuth, MDStudy ChairProvidence Health & Services
~68 spots leftby Sep 2025
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