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MinorTrial status: Recruiting to Active, Not Recruiting
Enrollment target: estimated 668 to confirmed 527
Study sites: 83 to 64
Primary completion date changed from estimate of Nov 2024 to Sep 4, 2024
v33
MinorStudy sites: 79 to 83
Eligibility criteria expanded, about 34 words
v32
MinorStudy sites: 78 to 79v31
Show 29 earlier versionsHide 29 earlier versions
MinorStudy sites revised (78)v30
MinorSite details revised at 4 of 78 sitesv29
MinorSite details revised at 3 of 78 sitesv28
MinorStudy sites: 71 to 78v27
MinorStudy sites: 70 to 71
Eligibility criteria expanded, about 3 words
v26
NotablePrimary completion date: Oct 2023 to Nov 2024
Study sites: 58 to 70
Study completion date: Oct 2027 to Oct 2030
Eligibility criteria expanded, about 17 words
v25
MinorSite details revised at 1 of 58 sitesv24
MinorSite details revised at 1 of 58 sitesv23
MinorStudy sites: 57 to 58v22
MinorStudy sites: 54 to 57v21
MinorSite details revised at 2 of 54 sitesv20
MinorStudy sites: 52 to 54v19
MinorSite details revised at 1 of 52 sitesv18
MinorStudy sites: 49 to 52v17
MinorStudy sites: 50 to 49v16
MinorStudy sites: 49 to 50
Eligibility criteria expanded, about 12 words
v15
MinorStudy sites: 28 to 49v14
MinorStudy sites: 27 to 28v13
MinorStudy sites: 26 to 27v12
MinorStudy sites: 24 to 26v11
MinorStudy sites: 23 to 24v10
MinorStudy sites: 25 to 23v9
MinorSite details revised at 2 of 25 sitesv8
MinorSite details revised at 1 of 25 sitesv7
NotableTrial status: Active, Not Recruiting to Recruiting
Enrollment target: 16 to 668
Site details revised at 25 of 25 sites
v6
NotableEnrollment target: estimated 688 to confirmed 16
Trial status: Recruiting to Active, Not Recruiting
Site details revised at 25 of 25 sites
v5
MinorSecondary endpoints revised (3)
Site details revised at 2 of 25 sites
Eligibility criteria expanded, about 2 words
v4
NotableTrial status: Not Yet Recruiting to Recruiting
Start date changed from estimate of Oct 2019 to Dec 12, 2019
Site details revised at 25 of 25 sites
v3
MinorStudy sites: 3 to 25v2
MinorStudy 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Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this research study is to evaluate whether using the the IMPELLA® CP System temporary circulatory assist device for 30 minutes prior to a catheterization procedure has the potential to reduce the damage to the heart caused by a heart attack, compared to the current standard of care.