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ACTIVE NOT RECRUITING NA

Impella ECP Early Feasibility Study

NCT04477603 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 100 participants
Start Date 2020-10-09
Est. Completion 2026-10-31
Phase NA

Sponsor

Abiomed

37 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04477603

The ClinicalTrials.gov registry entry for NCT04477603 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abiomed, which has 37 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04477603 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Michigan, Massachusetts, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04477603?

The interventions under investigation include: Impella ECP (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04477603?

This trial is sponsored by Abiomed, which has 37 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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