Impella ECP for High Risk Percutaneous Coronary Interventions

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
High Risk Percutaneous Coronary InterventionsImpella ECP - Device
Eligibility
18 - 90
All Sexes
What conditions do you have?
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Study Summary

This trial is testing how safe and effective the Impella ECP device is for people undergoing a high-risk heart procedure.

Treatment Effectiveness

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: through end of study, 30 days

Day 1
Feasibility: successful hemodynamic support
Procedural Success
Safety: Major Device-Related Adverse Events
Technical Success
Day 30
Rate of composite Major Device-Related Adverse Events
Rate of each individual Major Device-Related Adverse Event

Trial Safety

Trial Design

1 Treatment Group

Subjects receiving the Impella ECP
1 of 1

Experimental Treatment

100 Total Participants · 1 Treatment Group

Primary Treatment: Impella ECP · No Placebo Group · N/A

Subjects receiving the Impella ECP
Device
Experimental Group · 1 Intervention: Impella ECP · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through end of study, 30 days

Who is running the clinical trial?

Abiomed Inc.Lead Sponsor
35 Previous Clinical Trials
33,400 Total Patients Enrolled
1 Trials studying High Risk Percutaneous Coronary Interventions
224 Patients Enrolled for High Risk Percutaneous Coronary Interventions
Seth Bilazarian, MDStudy DirectorAbiomed Inc.
1 Previous Clinical Trials
256 Total Patients Enrolled
Shon Chakrabarti, MDStudy DirectorAbiomed Inc.
Duane Pinto, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center
1 Previous Clinical Trials
256 Total Patients Enrolled
Chuck Simonton, MDStudy DirectorAbiomed Inc.
1 Previous Clinical Trials
256 Total Patients Enrolled

Eligibility Criteria

Age 18 - 90 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are scheduled for an elective or urgent high risk percutaneous coronary intervention with hemodynamic support.