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Evaluation of the Efficacy of Early Implantation of a Percutaneous Left Ventricular Assist Devices in Acute Coronary Syndrome Complicated by Cardiogenic Shock Compared to Conventional Therapy: a Prospective, Multicenter, Randomized, Controlled and Open-label Clinical Trial

NCT05366452 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2023-01-25

No results posted yet for this study

Summary

The ULYSS study is a randomized, multicenter, interventional and prospective open-label clinical trial. It aims to evaluate the efficacy of the addition of an early IMPELLA CP support on top of optimal medical therapy and culprit lesion PCI compared to optimal medical care and culprit PCI in patients with an ACS complicated by a CS.

A transthoracic echography is required to exclude some non-inclusion criteria as soon as possible and before randomization.

Randomization will be performed after an informed consent is signed by the patient, a family member if he is unable to consent or thanks to the emergent consent procedure if all inclusion criteria are met and there are no non-inclusion criteria. A computer-generated randomization list will be drawn-up using a permuted block design (stratified on center). Each center will have a specific list.

Randomization 1:1 to one of the 2 groups

In all patients, emergent PCI of the culprit lesion will be performed.

* Control group: patients will receive IV inotropes associated or not with vasopressors according to the attached protocol and based on the current guidelines (annex 1) (2, 4) in addition to emergent culprit lesion PCI
* Experimental group: patients will receive IMPELLA CP before PCI on top of conventional therapy based on the same protocol as the control group and emergent culprit PCI

Conditions

  • Cardiogenic Shock

Interventions

DEVICE

IMPELLA CP

Implantation of the IMPELLA CP will be performed using the femoral route in most patients. Echo guided puncture to gain access for IMPELLA CP will be encouraged and a local angiography will be promoted to check the feasibility of device implantation. The implantation will follow gold standard after obtaining an ACT \>250 s. As soon as the device is in place it will be started.

OTHER

Conventional therapy

The patients will receive up to date management according to the consensus of care regarding inotropes and vasopressors in CS (2,4). A dedicated protocol will ensure that management is similar between centers and in both groups. The shock team will be in charge of all therapeutic decisions.

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • François CREMIEUX · Assistance Publique Hopitaux De Marseille

  • LAURENT BONELLO · Assistance Publique Hopitaux De Marseille

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-19
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05366452 on ClinicalTrials.gov