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| General |
| Study Status |
Redesigned/Replaced Study |
Application Number /
Requirement Number |
P140003 / PAS001 |
| Date Original Protocol Accepted |
11/13/2015
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| Date Current Protocol Accepted |
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| Study Name |
New Enrollment Study
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| Device Name |
IMPELLA 2.5 System
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Objective Performance Criterion
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| Analysis Type |
Analytical
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Objective: to evaluate the safety and effectiveness of the IMPELLA
2.5 System compared to a predefined Performance Goal (PG) based
on the PROTECT II 90 days Major Adverse Events (MAE) rates.
Design: a multicenter, prospective single arm study. This is a new enrollment study.
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| Study Population |
High risk subjects indicated for nonemergent percutaneous treatment after heart team evaluation including a cardiac surgeon of at least one de novo or restenotic lesion in a native coronary vessel
or bypass graft.
The high risk subjects are defined by the combination of anatomical and left ventricular function criteria:
a) Ejection Fraction =< 35% AND
¿ Intervention on the last patent coronary conduit
at least one of the following criteria:
¿ Intervention on an unprotected left main coronary artery
Or,
b) Ejection Fraction =< 30% and intervention on patient presenting with triple vessel disease.
Three-vessel or triple vessel disease is defined as at least one significant stenosis* in all three major epicardial territories: Left Anterior Descending Artery (LAD) and/or side branch, left circumflex artery (LCX) and/or side branch, Right Coronary Artery (RCA) and or side branch.
*Significant stenosis is defined as at least 50% diameter stenosis by visual estimate or any total occlusion. In the case of left coronary artery dominance, a lesion in the LAD and the proximal LCX qualifies as three-vessel disease.
No comparator group.
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| Sample Size |
A total of up to 70 sites will be enrolled. At least 20 or more sites will be non-IDE sites and will enroll 25-35% of the patients. No study center (site) is allowed to have more than 20% of all subjects. Assuming the true proportion of 90 day MAE is 0.45, a total of 335 evaluable subjects will provide 90% power to reject the null hypothesis with one-side alpha error of 5%. Assuming 10% loss to follow-up to 90 days, 369 subjects will be enrolled in the study.
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| Key Study Endpoints |
Main Safety Endpoints:
A composite rate of the following 10 intra-procedural and post-
procedural major adverse events (MAE) at 90 days post index
procedure.
1) Death
2) Myocardial infarction
3) Stroke/TIA
4) Repeat revascularization
5) Need for cardiac operation or thoracic or abdominal vascular operation or vascular operation for limb ischemia
6) Acute renal dysfunction
7) Increase in aortic insufficiency by more than one grade
8) Severe hypotension defined as systolic blood pressure <90 mmHg for >=5 min requiring inotropic/pressor medications or IV fluid
9) Cardiopulmonary resuscitation or Ventricular arrhythmia
requiring cardioversion
10) Failure to achieve angiographic success defined as residual stenosis <30% after stent implantation
Secondary Safety/Effectiveness Endpoints:
¿ Improved baseline hemodynamics post support initiation as
measured by maximal increase in Mean Arterial Pressure within
30 min of support initiation.
¿ Improvement in Left Ventricular Ejection Fraction (LVEF) at 90
days as compared to baseline
¿ Improvement in NYHA class at 90 days as compared to baseline
Additional Exploratory Endpoints:
1.Rate for each of the individual components of the composite
primary endpoint at 90 days;
2.Procedural safety endpoint: composite endpoint at 30 days post
index procedure including:
- Death
- Stroke or TIA
- Need for vascular operation
- Peri-procedural myocardial infarction
- Transfusion of 2 units of PRBCs
- Increase in aortic insufficiency by more than one grade
- Acute renal dysfunction
3. Procedure effectiveness endpoint: composite at 30 days post
index procedure, i.e. alive at 30 days with none of the following:
- Procedural hypotension requiring treatment
- Failure to achieve angiographic success
- Intra-procedural cardiopulmonary respiration or cardioversion.
3. Long term assessment (composite at 90 day and 1 year): Proportion of patients alive and none of the following: spontaneous myocardial infarction, repeat re-hospitalization for heart failure or repeat revascularization (PCI or CABG).
4. Composite endpoint at 90 days and 1 year post index procedure: Major Adverse Cardiac and Cerebrovascular Events (MACCE), including death, stroke, myocardial infarction, repeat revascularization
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| Follow-up Visits and Length of Follow-up |
1 year
Pre- and during the PCI procedure, immediately following the PCI procedure or device explant, in the ICU or the floor where the patient will spend the remainder of his or her hospital stay, at hospital discharge, 30 days, 90 days, and 1 year post PCI.
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