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The Pressure-controlled Intermittent Coronary Sinus Occlusion on VentrIcular PERformance Study

NCT04032925 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2023-08-21

No results posted yet for this study

Summary

The PICSO ViPER study is a prospective single centre cohort study of the use of PICSO in patients presenting acute myocardial infarction and impaired function of the left ventricle and candidate to angioplasty the left anterior descending (LAD) coronary artery.

The percutaneous coronary intervention (PCI) procedure will be undertaken in a standard fashion, in accordance with the Oxford University Hospitals NHS Trust (OUHT) departmental guidelines for PCI, and includes the use of pressure wire measurements before and after stent deployment. PICSO treatment will be added on top of the conventional treatment.

The protocol will constitute of 5 main stages (that will all be performed during index angioplasty procedure). The protocol is complete at the end of the angioplasty procedure, and the patient will exit the study at this point. The five stages of the protocol are described below (for details see "Detailed Description"):

* Baseline
* PICSO treatment during pre-dilation
* Stenting with PICSO support
* Post-stent Physiology
* PICSO treatment during post-dilation

Conditions

Interventions

DEVICE

PICSO

PICSO therapy is delivered through the PICSO Impulse System, which consists of the PICSO Impulse console and PICSO impulse catheter. The PICSO therapy is delivered in each patient for a minimum of 20 minutes to a maximum of 45 minutes. The PICSO Impulse catheter is automatically activated by the PICSO Impulse console. It is inserted in the coronary sinus via femoral vein access. The PICSO Impulse Console cyclically inflates and deflates the balloon at the tip of the PICSO Impulse catheter, generating transient increase in coronary sinus pressure.

Sponsors & Collaborators

  • Miracor Medical SA

    collaborator INDUSTRY

  • Oxford University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Giovanni Luigi De Maria, MD, PhD · Oxford University Hospitals - NHS Foudation Trust

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-08-03
Primary Completion
2022-12-29
Completion
2022-12-29

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT04032925 on ClinicalTrials.gov