Impella®-supported PCI in high-risk patients with complex coronary heart disease and reduced left ventricular function: The PROTECT IV study

ICTRP Studien-ID
NCT04763200 (ICTRP)

Offizieller Titel (Genehmigt von der Ethikkommission)
Impella®-Supported PCI in High-Risk Patients with Complex Coronary Artery Disease and Reduced Left Ventricular Function: The PROTECT IV Trial (BASEC)

Wissenschaftlicher Titel
Impella-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function: The PROTECT IV Trial (ICTRP)

Öffentlicher Titel
Impella-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function (ICTRP)

Untersuchte Krankheit(en)
Left Ventricular DysfunctionCoronary Artery Disease (ICTRP)

Untersuchte Intervention
Device: Impella CP / Impella CP with SmartAssist / Impella 2.5Device: IABP Intra-aortic balloon pump (ICTRP)

Studientyp
Interventional (ICTRP)

Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Ein-/Ausschlusskriterien
Inclusion Criteria:

1. Age =18 years and =90 years

2. Clinical presentation and baseline left ventricular function are as follows: Either
2A or 2B must be present

A. Subject has CCS or NSTEMI with an LVEF =40% NOTE: The LVEF must be quantitatively
measured as =40% by echo within 30 days assuming no change in clinical condition. If
multiple echos have been performed within 30-days, the most recent test must be used
to qualify the patient. NOTE: Subject qualifies if the quantitative site read LVEF
is =30% if the quantitative site read is >30% - =40% the Echo Core Lab must confirm
the LVEF is =40% before subject enrollment (Core Lab will provide <48-hour
turnaround). Similarly, if the site read is qualitative only (i.e., only provides
broad ranges without detailed LVEF quantification), the Echo Core Lab must confirm
the LVEF is =40% before subject enrollment.

OR

B. Subject has STEMI =24 hours and <30 days after symptom onset with an LVEF =30%
NOTE: In patients qualifying with recent STEMI, the LVEF must be demonstrated to be
=30% by quantitative echocardiography after the primary PCI procedure (if performed)
and within 72-hours prior to the planned randomization. If primary PCI was not
performed, the qualifying echocardiogram will be the one taken during the index
hospitalization closest to the index procedure. If the site read is qualitative only
(i.e., only provides broad ranges without detailed LVEF quantification), the Echo
Core Lab must confirm the LVEF is =30% before subject enrollment.

3. Local heart team (interventional cardiologist and cardiac surgeon) has determined
that PCI is indicated and is the most appropriate management for the patient

4. Complex PCI will be performed: Either 4A or 4B must be met

A. One of the following must be present:

i. Triple vessel disease is present (visually-assessed angiographic DS =80% [or =40%
if non-invasive evidence of ischemia on a localizing stress test or invasive
evidence of ischemia (FFR =0.80 or iFR =0.89)] is present in all 3 epicardial
coronary artery distributions in a main vessel or branch with visually-assessed
reference vessel diameter =2.5 mm) with PCI planned in =2 of these vessels in the
proximal or mid LAD, proximal or mid-LCX or proximal, mid- or distal RCA [i.e., not
a branch vessel])

OR

ii. Left main distal bifurcation or trifurcation disease (visually-assessed DS =50%
[or DS =30% if non-invasive evidence of ischemia in both the anterior and
posterolateral distributions or left main IVUS MLA =6.0 mm2 or FFR =0.80 or iFR
=0.89] is present) with planned intervention of the left main plus at least 2 branch
vessels (i.e., the ostial LAD, ostial LCX or ostial ramus)

OR

iii. Left main equivalent disease with both ostial LAD and ostial LCX having
visually-assessed angiographic DS =80% [or =40% if non-invasive evidence of ischemia
on a localizing stress test or invasive evidence of ischemia (FFR =0.80 or iFR
=0.89] and requiring intervention in both branches

OR

iv. Intervention of the last remaining vessel (native coronary artery or bypass
graft)

OR

B. Multivessel disease is present (visually-assessed angiographic DS =80% [or =40%
if non-invasive or invasive evidence of ischemia is present] in =2 of the 3
epicardial coronary artery distributions in a main vessel or branch with
visually-assessed reference vessel diameter =2.5 mm) and PCI is planned of at least
2 separate complex lesions in main vessels or branch vessels each having one or more
of the following characteristics:

i. Long lesion (=28 mm visually assessed) requiring =30 mm stent length (single or
multiple)

ii. Severe angiographic calcification (see Protocol definition) or requiring
atheroablation

iii. Any left main morphology not in Criterion A requiring intervention (e.g.,
isolated ostial or mid-shaft left main lesion or distal left main bifurcation lesion
with a planned single provisional stent technique)

iv. Non-left main bifurcation lesion requiring intervention in both the main branch
and side branch

v. CTO (TIMI 0 Flow)

vi. Giant thrombus (length =3x vessel diameter)

vii. SVG (other than focal (<5 mm) disease of the proximal or distal anastomosis or
in-stent restenosis)

NOTES:

1. The multiple lesions can be in the same vessel if separated by =10 mm -
however, each separate lesion has to have one or more of the above
characteristics

2. PCI may be performed on additional non-qualifying lesions (i.e., without 1 or
more of the above high-risk characteristics) as long as there are at least two
lesions also undergoing PCI with each having 1 or more of the above
characteristics)

3. There are 2 exceptions to the rule that each separate lesion must have one or
more of the above characteristics (as in Inclusion Criterion 4B above): The
subject may qualify if undergoing complex PCI of a single lesion that has 2 or
more of the above complex characteristics (as in Inclusion Criterion 4B above)
if also:

i. There is a CTO of a proximal or mid-LAD, proximal or mid-LCX or proximal, mid- or
distal RCA (i.e., not a branch vessel) that will not be treated

OR

ii. The subject qualifies with recent STEMI with an LVEF =30% and the complex PCI is
planned in a non-infarct vessel (i.e., a complex PCI in the infarct vessel does not
qualify)

5. Subject or legal guardian (permitted at US sites only) agrees to randomization and
to follow all study procedures and provides informed, written consent

Exclusion Criteria:

Subjects must not meet ANY of the following Exclusion Criteria to participate in the
Trial:

1. STEMI =24 hours from the onset of ischemic symptoms or at any time if mechanical
complications of transmural infarction are present (e.g., VSD, papillary muscle
rupture, etc.)

2. Cardiogenic shock (SBP <80 mmHg for =30 mins and not responsive to intravenous
fluids or hemodynamic deterioration for any duration requiring pressors or
mechanical circulatory support, including IABP)

3. Subject is presently or recently intubated for the current admission (NOTE: recently
intubated patients must be extubated for >24 hours with full neurologic recovery)

4. Cardiorespiratory arrest related to the current admission unless subject is
extubated for >24 hours with full neurologic recovery and hemodynamically stable

5. Any contraindication or inability to Impella placement in both the left and right
common femoral artery based on clinical or imaging findings, including iliofemoral
artery diameter <5 mm, tortuous vascular anatomy or severe bilateral peripheral
vascular disease of the iliac or femoral arteries that can't be adequately treated
(e.g., with intravascular lithotripsy)

NOTES:

1. Computed tomography (CT), magnetic resonance angiography (MRA) or contrast
angiography to assess the aorta and iliofemoral vasculature to ensure Impella
compatibility must be performed within 90 days pri (ICTRP)

nicht verfügbar

Primäre und sekundäre Endpunkte
The composite of all-cause death, stroke, MI, unplanned clinically driven revascularization, durable LVAD implant or heart transplant, or other hospitalization for cardiovascular (CV) causes. (ICTRP)

Death or NYHA Class III or IV;Improvement in KCCQ;6MWD;All CV hospitalizations through 3 years;Composite of CV death, stroke, MI, unplanned clinically driven revascularization, durable LVAD implant or heart transplant, or other hospitalization for cardiovascular causes through 3 years;CV death or HF hospitalizations through 3 years;Improvement in LVEF based on ANCOVA regression with inclusion of baseline LVEF measurement as a covariate;Achievement of complete anatomic revascularization after the index and planned staged procedures (ICTRP)

Registrierungsdatum
nicht verfügbar

Einschluss des ersten Teilnehmers
nicht verfügbar

Sekundäre Sponsoren
nicht verfügbar

Weitere Kontakte
Charles (Chuck) Simonton, MD FACC FSCAI, csimonton@abiomed.com, 978-646-1597 (ICTRP)

Sekundäre IDs
VV-TMF-18508 (ICTRP)

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar

Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT04763200 (ICTRP)