Effect of IMPELLA on coronary microcirculation in patients with left ventricular dysfunction and coronary artery disease

Effect of IMPELLA on coronary microcirculation in patients with left ventricular dysfunction and coronary artery disease (CoroPELLA study) - CoroPELLA study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000055332

Enrollment

Registered

2024-08-26

Start date

2024-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronary artery disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients undergoing high-risk percutaneous coronary intervention (fulfilling one of the following clinical and/or anatomical high-risk criteria: clinical characteristics [left ventricular ejection fraction <35%, hemodynamic instability, diabetes mellitus, acute coronary syndromes, previous cardiac surgery, chronic kidney disease], angiographic characteristics [diffuse coronary artery disease, multivessel disease, unprotected left main coronary disease involving bifurcation, severely calcified lesions needing rotational atherectomy, last patent conduit]) with hemodynamic support by IMPELLA.

Exclusion criteria

Exclusion criteria: Congenital heart disease, cardiac shunt, coronary vessels with chronic total occlusion (CTO), or donor arteries of the CTO lesions.

Design outcomes

Primary

Measure	Time frame
Change in IMR (index of microvascular resistance) from baseline to maximum IMPELLA flow	—

Secondary

Measure	Time frame
Change in the following variables between time points A-F except for the primary outcome. Variables: index of microvascular resistance (IMR), coronary flow reserve (CFR), fractional flow reserve (FFR), resistive reserve ratio (RRR), pressure-bounded CFR (PB-CFR), corrected IMR, CFR norm (CFR/FFR), mean transit time (rest), and mean transit time (hyperemia). Timepoints: A, Baseline; B, Low IMPELLA flow (P2); C, Maximum IMPELLA flow; D, post-PCI maximum IMPELLA flow; E, post-PCI low IMPELLA flow (P2); F, After IMPELLA decannulation.	—

Measure

Time frame

Change in the following variables between time points A-F except for the primary outcome. Variables: index of microvascular resistance (IMR), coronary flow reserve (CFR), fractional flow reserve (FFR), resistive reserve ratio (RRR), pressure-bounded CFR (PB-CFR), corrected IMR, CFR norm (CFR/FFR), mean transit time (rest), and mean transit time (hyperemia). Timepoints: A, Baseline; B, Low IMPELLA flow (P2); C, Maximum IMPELLA flow; D, post-PCI maximum IMPELLA flow; E, post-PCI low IMPELLA flow (P2); F, After IMPELLA decannulation.

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Countries

Japan

Contacts

Public ContactSho Suzuki

Department of Cardiovascular Medicine Department of Cardiovascular Medicine

jersey0042@gmail.com81-263-37-3486

Outcome results