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Impella ECP Study (ECP Study) and Impella ECP Continued Access Protocol

StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Dec 31, 2025 to Dec 31, 2026v17
  2. Re-verified, no change to tracked fieldsv16
  3. Enrollment target: 556 to 856v15
  4. Study sites revised (32)v14
  5. Re-verified, no change to tracked fieldsv13
Show 11 earlier versionsHide 11 earlier versions
  1. Primary completion date: Dec 31, 2024 to Dec 31, 2025
    • Study completion date: Jan 31, 2025 to Dec 31, 2026
    • Study description revised
    v12
  2. Primary completion date: Sep 30, 2024 to Dec 31, 2024
    • Study completion date: Oct 31, 2024 to Jan 31, 2025
    v11
  3. Study sites revised (32)v10
  4. Enrollment target: 256 to 556v9 Show 7 more changesShow less
    • Primary completion date: Sep 30, 2023 to Sep 30, 2024
    • Trial status: Recruiting to Enrolling by Invitation
    • Study completion date: Dec 31, 2023 to Oct 31, 2024
    • Study description expanded, about 49 words
    • Site details revised at 32 of 32 sites
    • Study title expanded, about 6 words
    • Eligibility criteria expanded, about 3 words
  5. Study sites: 27 to 32v8
  6. Study sites: 18 to 27v7
  7. Study sites: 11 to 18
    • Primary completion date: Aug 31, 2023 to Sep 30, 2023
    v6
  8. Study sites: 9 to 11v5
  9. Primary completion date: Jun 30, 2023 to Aug 31, 2023
    • Study completion date: Oct 31, 2023 to Dec 31, 2023
    v4
  10. Study sites: 1 to 9
    • Primary completion date: May 1, 2023 to Jun 30, 2023
    • Study completion date: Oct 1, 2023 to Oct 31, 2023
    v3
  11. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 1, 2022 to Dec 20, 2022
    • Study sites: 0 to 1
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Abiomed Inc.
13 trials monitored
See 1 trial at risk
The Impella ECP Study is a prospective, multi-center, single-arm study evaluating the rate of major adverse cardiovascular and cerebrovascular events (MACCE) with the Impella ECP device in adult patients undergoing elective or urgent high-risk percutaneous coronary intervention. The above applies to Impella ECP Continued Access Protocol
Trial Details
NCT Number NCT05334784
Lead Sponsor Abiomed Inc.
Conditions
(from sponsor)		 High-Risk Percutaneous Coronary Intervention
Enrollment 856 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov