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NCT04477603 · ClinicalTrials.gov registry record · NA
Impella ECP Early Feasibility Study
A NA study of High-risk Percutaneous Coronary Intervention, sponsored by Abiomed.
- Active
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 5
- Study locations
NCT04477603: Active NA study of High-risk Percutaneous Coronary Intervention, sponsored by Abiomed.
NCT04477603 is a NA study of High-risk Percutaneous Coronary Intervention that is active but no longer recruiting, run by Abiomed. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04477603, a NA study of High-risk Percutaneous Coronary Intervention, is active but no longer recruiting, sponsored by Abiomed.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 5
- Study locations
Study Summary
The Impella ECP EFS is a prospective, multicenter, single-arm, feasibility study evaluating the safety of the Impella ECP device in adult patients undergoing an elective or urgent high-risk percutaneous coronary intervention.
Primary Outcome
The feasibility assessment is defined as the successful delivery, initiation and maintenance of sufficient hemodynamic support to increase in or maintenance the MAP at physiologic levels (\> 60 mmHg)
Conditions Studied
Interventions
- DEVICE Impella ECP
Study Locations (5)
Michigan
- Henry Ford Hospital - Detroit
- Henry Ford Health St. John Hospital - Detroit
Massachusetts
- Tufts Medical Center - Boston
New Jersey
- The Valley Hospital - Paramus
Ohio
- The Christ Hospital - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2020-10-09 |
| Est. Completion | 2026-10-31 |
| Phase | NA |
What the registry record for NCT04477603 still lists
NCT04477603 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 1 condition, with High-risk Percutaneous Coronary Intervention appearing as the primary indexed condition, and to 1 intervention - of which Impella ECP is the first listed.
NCT04477603 lists 5 locations in 4 states (Michigan, Massachusetts, New Jersey).
Frequently Asked Questions
What is clinical trial NCT04477603 about?
NCT04477603 is a clinical study titled "Impella ECP Early Feasibility Study". The Impella ECP EFS is a prospective, multicenter, single-arm, feasibility study evaluating the safety of the Impella ECP device in adult patients undergoing an elective or urgent high-risk percutaneous coronary intervention.
What is the current status of trial NCT04477603?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2020-10-09. Estimated completion is 2026-10-31.
What conditions does trial NCT04477603 study?
This clinical trial studies the following conditions: High-risk Percutaneous Coronary Intervention.
What interventions are being tested in trial NCT04477603?
The interventions under investigation include: Impella ECP (DEVICE).
Who is sponsoring clinical trial NCT04477603?
This trial is sponsored by Abiomed, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04477603 being conducted?
This trial has 5 study locations across Massachusetts, Michigan, New Jersey, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04477603's enrollment target sits among peer trials
100 840th of 2000 higher than 1,081 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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